MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 04/18/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a patient presenting with a ruptured abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2023, the endoprosthesis was explanted due to an infection of an unknown type.It is unknown whether the infection predated the implantation.

Manufacturer Narrative

H3-code: the medical device returned to a third party for further investigation.The analysis report was shared with gore and evaluated appropriately.H6-code b13: additional information to the event has been requested.The serial number of the device was requested but remains unknown.Therefore a review of the manufacturing records could not be performed.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

The physician has sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted gore® excluder® conformable aaa endoprosthesis after cleaning) was performed by the third party.The explanted device was not returned to gore for evaluation.Instead, they provided analysis results to gore, which were reviewed by gore explant scientists.No abnormalities were observed on the explanted device.Additional analysis of the specimen may only prove the presence of infection, with no additional information regarding the cause of the detected infection.Therefore an additional analysis of the device is not required.Requests were emailed to the third party to provide additional information to the incident and the device.The requests remained unanswered.A unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.In the instructions for use the following is stated: potential device or procedure related adverse events adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoprosthesis or delivery system: infection; infection (e.G., aneurysm, device or access sites).

Event Description

It was reported that on (b)(6) 2023, a patient presenting with a ruptured abdominal aortic aneurysm was treated with a gore® excluder® conformable aaa endoprosthesis.On (b)(6) 2023, the endoprosthesis was explanted due to an infection of an unknown type.The type of repair of the lesion remains unknown.It is unknown whether the infection predated the implantation.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: kerstin haberlaender ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17144296
• MDR Text Key: 317445854
• Report Number: 3007284313-2023-02530
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 09/29/2023
• Supplement Dates FDA Received: 08/31/2023; 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male