| Public Health Service Food and Drug Administration |
| Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human ServicesMarch 12, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-18
Thierry B. Thaure, Chief Executive Officer
EndoGastric Solutions, Inc.
8210 154th Avenue Northeast
Redmond, Washington 98052
WARNING LETTER
Dear Mr. Thaure:
During an inspection of your firm located in Redmond, Washington on September 11, 2009 through September 30, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the EsophyX2 device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
Our inspection revealed that your device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to submit a report to FDA after receiving information that reasonably suggested that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(2).
For example, our investigation found that your firm was notified that the EsophyX2 had malfunctioned during a surgical operation; however, you did not report this as an MDR event. Specifically you were notified of an occurrence, which you recorded as Complaint 2009-0196, on August 12, 2009, which involved the service loop disconnecting from the tissue mold at the distal end of the device allowing the metal helical retractor to dangle. Subsequently, your complaint report states the side of the helical retractor "caught the esophageal 1/3 of the way out" during attempted removal of the device requiring a biopsy forceps to loosen the helical retractor enough for removal of the device. Our investigation also noted that two weeks prior to this, on July 29, 2009, you received a complaint concerning the EsophyX2 involving injury to the proximal end of a patient's esophagus during removal of the device. This was reportedly caused by a pin exiting the posterior side of the tissue mold between the junction of the elbow and the first link. The information in the complaint files indicates that your firm was in possession of information that reasonably suggested that your marketed device malfunctioned and this device would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. Your firm failed to submit this report to FDA within the required 30 day timeframe as required by 21 CFR 803.50(a)(2).
2. Failure to develop, maintain, and implement written MDR procedures and MDR event files for internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17 and 803.18.
Our investigation found that three occurrences, which you recorded as Complaints 2009-0156, 2009-0182, and 2009-0196, failed to provide adequate documentation including, but not limited to, the following:
a) Where, exactly, in the patient's esophagus the broken piece of device landed and what injury it-caused to the esophageal tissue against which it both moved and landed such as whether it caused or could cause significant esophageal cut, perforation or obstruction.
b) Whether removal of the broken piece of device would be considered medically/surgically inconsequential or necessary to preclude permanent impairment or damage.
c) What efforts were made to obtain patient information.
d) What deliberations were made to determine MDR reportability.
e) What investigation was conducted to determine if the device met durability specifications, as alleged (per documentation),
f) What problem was evaluated that resulted in the documentation - "problem confirmed - no" and the basis of the assessment that the problem was not confirmed.
Our inspection and subsequent website review also revealed that your device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g), relating to the device's use ill pediatric patients. This device is also misbranded under section 502(0) of the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k), with respect to pediatric use. For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency under 21 C.F.R. 807.81(b).
The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. FDA will evaluate the information you submit and decide whether your product may be
legally marketed for pediatric use.
The 510(k) notification that was originally submitted with respect to your device and for which it was subsequently cleared, indicated the device was intended for use in adult patients. This is based on the clinical study data submitted with your original 510(k) notification which showed that the clinical study of the device was conducted in adults between the ages of 18 and 80. The original notification did not indicate the device was intended for use in pediatric patients; however, your firm's website http://www.endogastricsolutions.com includes a video titled "Video on First Pediatric EsophyX TIF Procedure," depicting the use of the device on a pediatric patient.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington, 98021-4421. If you have any questions about the content of this letter please contact Mr. Donovan at (425) 483-4906.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely,
/s/
Charles M. Breen
District Director
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