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

Catalog Number CXT281412

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/29/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular treatment of a ruptured abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis.Angiography performed after all stent grafts implantation revealed that the left renal artery was covered about 3mm by the trunk - ipsilateral leg endoprosthesis.Although there was no blood flow delay, a bare metal stent was implanted in the left renal artery to prevent occlusion.Final angiography showed a proximal type i endoleak, but the endoleak was not treated and decided to be monitored.The patient tolerated the procedure.The physician reportedly stated as follows: because the proximal neck was poor, i wanted to implant the trunk - ipsilateral leg endoprosthesis with the position where the first stent line positioned just below the left renal artery.Therefore, it was expectable that the left renal artery could be covered by the trunk - ipsilateral leg endoprosthesis a little.

Manufacturer Narrative

H6: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H6: code b20: device remains implanted and therefore not available for direct analysis.H6: code a27: used to capture left renal artery was covered about 3mm by the trunk - ipsilateral leg endoprosthesis.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

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.Additionally, the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: patients with less than 15 mm in length or > 60° angulation of the proximal aortic neck.Additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak and device/native vessel obstruction and, or occlusion.Improper component placement, and component migration.

Manufacturer Narrative

G.3: pma/510(k)number p020004 corrected to p200030.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18384202
• MDR Text Key: 331290999
• Report Number: 3007284313-2023-02974
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651054
• UDI-Public: 00733132651054
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200030
• 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,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CXT281412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Male