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

Catalog Number CXT361414

Device Problem Patient-Device Incompatibility (2682)

Event Date 11/22/2023

Event Type  Injury  

Event Description

On november 30, 2023, the gore representative became aware of a non-emergent device explant.It was reported that the patient underwent explant of gore® excluder® conformable aaa endoprostheses on (b)(6) 2023.It was observed that the device had no proximal seal and the patient's aneurysm was growing.It was reported that on (b)(6) 2023, the patient was still in-house and intubated.

Manufacturer Narrative

Additional devices included in this file are as follows: catalog #plc161200/ serial #(b)(6) / udi #(b)(4).Catalog #plc141400/ serial #(b)(6) / udi #(b)(4).H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation will 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

A.4.Patient weight: asked but unavailable.B.5.Updated event description added.B.7.Other relevant history, including preexisting medical conditions: asked but unavailable.D.10.Concomitant medical products and therapy dates: asked but unavailable.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation findings for imaging evaluation: code c19 - an imaging evaluation was performed by a clinical imaging specialist on one provided jpeg image dated (b)(6) 2023.The evaluation found that the proximal gore® excluder® conformable aaa endoprosthesis appeared to be located at the level of the l-2 vertebral body.Unable to confirm lack of proximal seal, lack of circumferential device apposition, and/or aneurysm growth with the image provided.H.6.Investigation conclusions: code d15 added.According to the gore® excluder® conformable aaa endoprosthesis instructions for use, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak, aneurysm enlargement, and surgical cut down, bypass or conversion.H.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation findings for imaging evaluation: code c21 updated to code c19.H.6.Investigation findings for communication/interviews: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d12.

Event Description

On (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprostheses.On (b)(6) 2023, the gore representative became aware of a non-emergent device explant.It was reported that the patient underwent explant of the gore® excluder® conformable aaa endoprosthesis system on (b)(6) 2023.It was observed that the device had no proximal seal and the patient's aneurysm was enlarging (amount of growth unknown).The cause of the lack of proximal seal of the trunk-ipsilateral leg component was unknown.It was reported that on (b)(6) 2023, the patient was still in-house and intubated.Additional information was unavailable.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18421765
• MDR Text Key: 331667380
• Report Number: 3007284313-2023-02983
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651078
• UDI-Public: 00733132651078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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: 04/21/2023
• Device Catalogue Number: CXT361414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• 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: 62 YR
• Patient Sex: Male