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

Model Number PLC271200

Device Problem Material Invagination (1336)

Patient Problem Aneurysm (1708)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprostheses states; adverse events that may occur and / or require intervention include but are not limited to: endoprosthesis: component migration; occlusion the imaging evaluation performed by a clinical imaging specialist showed the following: two movies provided for evaluation, one 34 second video (img_3118), pages 2-3 and one 23 second video (img_3120), page 4 with screen captures of still images are below.Images cannot be manipulated in anyway.The observed crescent-shaped appearance of the device is consistent with device compression.Occlusion of the graft is also visualized.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

On (b)(6) 2023, this patient underwent treatment for abdominal aortic aneurysm and a unilateral common iliac artery aneurysm (ciaa) and was implanted with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).The patient tolerated the procedure.On (b)(6) 2023, the physician reported that the patient underwent reintervention on (b)(6) 2023 due to infolding of the trunk ipsilateral leg component and the proximal bridge graft (plc271200) to the iliac branch component.It was reported that an axillo-bifemoral bypass was performed.No explant of any of the devices was reported.The patient tolerated the procedure.A cause of the infolding was not provided.

Manufacturer Narrative

Engineering evaluation showed: · the gore® excluder® contralateral leg component plc271200 remained implanted and was not returned for analysis.· the device evaluation was performed based on what was reported to gore and images, including an imaging evaluation, attached to the event in the smartsolve complaint system as the device was not returned for analysis.· the imaging evaluation concluded: the observed crescent-shaped appearance of the device is consistent with device compression.Occlusion of the graft is also visualized.· the findings from the imaging evaluation are consistent with the physician¿s observation of ¿infolding of the trunk ipsilateral leg component and the proximal bridge graft (plc271200) to the iliac branch component.· the likely cause for the physician¿s observation of ¿infolding of the trunk ipsilateral leg component and the proximal bridge graft (plc271200) to the iliac branch component.¿ could not be determined from the information provided.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16578066
• MDR Text Key: 311658292
• Report Number: 3013164176-2023-01649
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618545
• UDI-Public: 00733132618545
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P02004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PLC271200
• Device Catalogue Number: PLC271200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2022
• 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; Other; Hospitalization
• Patient Age: 92 YR
• Patient Sex: Male