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

Model Number	PLC141000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022 a patient was treated for an abdominal aortic aneurysm with a gore® excluder® conformable aaa endoprosthesis.The main trunk device was extended with gore® excluder® aaa endoprosthesis contralateral leg endoprostheses.During the procedure, the trunk device landed 5 mm below the left renal artery.The physician declined to reconstrain and reposition due to the patient's poor kidney condition.The right internal iliac artery was intentionally overstented.At the conclusion of the procedure, imaging reportedly showed distal migration of 15 mm and overstenting of the left internal iliac artery.The physician is taking a wait and see approach and is currently monitoring the patient for potential complications.
Additional Manufacturer Narrative
Device remains implanted.Gore® excluder® conformable aaa endoprosthesis (sn (b)(4)).Imaging has been requested from the physician so a product evaluation can be carried out.
Additional Manufacturer Narrative
Medwatch #3007284313-2022-01926 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch (and supplementals) will be retracted.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14460470
• Report Number: 3007284313-2022-01926
• Device Sequence Number: 14627624
• Product Code: MIH
• UDI-Device Identifier: 00733132618637
• UDI-Public: 00733132618637
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2024
• Device Model Number: PLC141000
• Device Catalogue Number: PLC141000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Male