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 Retraction Problem (1536)

Event Date 06/28/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the patient was treated for an abdominal aortic aneurysm.The physician inserted a gore® excluder® conformable aaa endoprosthesis, and it partially covered the right renal artery.The physician attempted to pull the device down, but was unsuccessful, so decided to reconstrain the device.The result was that the left side of the device folded downward rather than having the two markers coming together.Further attempts to reconstrain were unsuccessful, so the physician decided to complete the deployment.A type ia endoleak was seen, so the physician added a conformable extender.A small type ia endoleak remained, but the physician felt it would resolve on its own, and ended the procedure.The patient tolerated the procedure.

Manufacturer Narrative

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

Imaging evaluation: summary: the imaging evaluation performed by a clinical imaging specialist showed the following: four jpeg images available for evaluation.No name, date(s), or demographics on the images.Cannot manipulate or window level images.The proximal device appears to be partially constrained.Proximal aspect of the partially constrained excluder® device appears to be perpendicular to the abdominal aorta that is just distal to the renal arteries.The most proximal radiopaque marker on the 3rd jpeg image appears to be encroaching on the right renal artery origin, on the projection provided.The last jpeg image shows the presence of an aortic extender proximally.Contrast shows a highly angulated aorta distal to the renal arteries.Possible contrast outside the proximal devices, however, the image provided is too dark to confirm.The renal arteries are patent.Engineering evaluation: images were provided for consideration and were evaluated by the imaging team.Based on the findings from the imaging evaluation, the statements from the event description that ¿the physician inserted a gore® excluder® conformable aaa endoprosthesis, and it partially covered the right renal artery¿ and ¿further attempts to reconstrain were unsuccessful¿ could be confirmed.The engineering evaluation of the provided images did not yield any additional conclusions.The root cause could not be determined with the available information and no manufacturing deficiencies were identified.As a result, a capa request is not required per (b)(4), engineering evaluation task procedure.This type of event will continue to be monitored per (b)(4), procedure for event trending, analysis, and review.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17379178
• MDR Text Key: 319662341
• Report Number: 3007284313-2023-02654
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651054
• UDI-Public: 00733132651054
• 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: 08/23/2023

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 Catalogue Number: CXT281412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 08/23/2023
• Date Device Manufactured: 12/15/2022
• 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 Sex: Female