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

Catalog Number PXC201000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Embolism/Embolus (4438)

Event Date 07/01/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6)2013, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.A left leg device was implanted to the left common iliac artery.On an unknown date, (b)(6) 2023, a computed tomography revealed an enlarged aneurysm diameter and occlusion of the left external iliac artery.On (b)(6) 2023, a reintervention was performed for the endoleak.A dilation of the left common iliac artery was observed.Two gore® viabahn® endoprosthesis with heparin bioactive surface devices were additionally implanted from the bifurcation to the left internal iliac artery.The left external iliac artery remained occluded, but no further treatment was given.The patient tolerated the procedure.The physician reportedly stated that the enlarged aneurysm diameter was caused by the distal type i endoleak.The physician did not know what caused the occlusion.

Manufacturer Narrative

H.6.: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.: code b20: device remains implanted and therefore not available for direct analysis.H.6.: code d12: according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleak.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), physician and patient should review the risks and benefits when discussing this endovascular device and procedure, including possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular repair.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

Additional information for this case from the fsa november 10, 2023.Gore aware date: november 9, 2023.Description: on unknown date, but about one (1) week after being discharged from the hospital, the patient passed away of disseminated intravascular coagulation (dic).The physician stated that it was unfortunate because the procedure itself went well and the postoperative course was good.It was unclear whether there was an endoleak or some other cause.

• Brand Name: GORE® EXCLUDER® 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18080176
• MDR Text Key: 327485789
• Report Number: 3007284313-2023-02876
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132610037
• UDI-Public: 00733132610037
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: PXC201000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2012
• 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): Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male