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

Model Number	PLC141400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant history: patient comorbidities include but are not limited to: coronary artery disease, hypertension, copd, patient medications include but are not limited to: aspirin, acetaminophen and heparin concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: plc141200/ 23086379 (udi: (b)(4)).The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis and the gore® excluder® iliac branch endoprosthesis is states, adverse events that may occur and / or require intervention include but are not limited to: pseudoaneurysm.
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on (b)(6) 2021, the patient was implanted with two gore® contralateral leg endoprostheses and a gore® iliac branch endoprosthesis with the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).Four the patient was being treated for an aortic aneurysm involving the visceral vessel(s).It was reported that on (b)(6) 2021, images revealed a pseudoaneurysm of left femoral artery.The adverse event was resolved.
Additional Manufacturer Narrative
Correction this medwatch will be retracted, as there is no product problem or deficiency caused or contributed to an adverse event/incident for the patient on these devices.Plc141400/23098439 and plc141200/23086379.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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: 14794516
• Report Number: 3013164176-2022-01410
• Device Sequence Number: 5058371
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: 00733132618651
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: PLC141400
• Device Catalogue Number: PLC141400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 101 KG