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

Catalog Number PXC201200J

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Aneurysm (1708); Obstruction/Occlusion (2422)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

H.6.Investigation findings code c19: the device remains implanted and is not available for analysis.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d12: it should be noted that, per the gore® excluder® aaa endoprosthesis instructions for use, complications associated with the use of the gore® excluder® aaa endoprosthesis that may occur include, but are not limited to, aneurysm enlargement, endoleak, native vessel obstruction, and reintervention.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.

Event Description

The following information was reported to gore: on (b)(6) 2013, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.A minor type ia endoleak was found, but the procedure was concluded as it was.The patient tolerated the procedure.On (b)(6) 2023, a follow-up ct scan showed a suspected type ib endoleak of the right side and aneurysm enlargement.Therefore, a reintervention was indicated.On (b)(6) 2023, the right internal iliac artery was coil-embolized and two additional contralateral leg components were implanted.The final angiography showed no endoleak.The patient tolerated the procedure.The reporting physician commented as follows: no obvious endoleak was found by the ct scan; however, the right common iliac artery was dilated and the device apposition was lost, so the additional devices were placed to extend treatment area into external iliac artery.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17817956
• MDR Text Key: 324264225
• Report Number: 3007284313-2023-02770
• Device Sequence Number: 1
• Product Code: MIH
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

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: 05/31/2016
• Device Catalogue Number: PXC201200J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2013
• 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): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male