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

Model Number	PXT231414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, embolization(micro and macro) with transient or permanent ischemia, aneurysm enlargement.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On an unknown date, a type ii endoleak and aneurysm enlargement were observed.On (b)(6) 2019, the patient underwent reintervention and a lumbar artery was coil embolized.The patient tolerated the procedure.On (b)(6) 2019, the patient underwent reintervention and a second lumbar artery underwent embolization using n-butyl-2-cyanoacrylate.The patient tolerated the procedure.On an unknown date, enlargement of the aneurysm persisted, a type i endoleak or type ii endoleak were suspected.On (b)(6) 2021, the patient underwent open conversion.The aneurysm sac was resected.The trunk - ipsilateral leg endoprosthesis was cut just above the flow divider, and the lumbar artery was ligated.Stump plasty of the device was performed, and it was anastomosed to the y-shaped graft.The distal sides of the y-shaped graft was anastomosed to the native blood vessels of the bilateral common iliac arteries.The inferior mesenteric artery was anastomosed to the left limb of the y-shaped graft.No proximal type i endoleak was observed.However, a type ii endoleak from the lumbar artery near the contralateral gate was observed.The patient tolerated the procedure.The physician stated that it was type ii endoleak, although it was not clear on computed tomography image.
Additional Manufacturer Narrative
D11: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pxc201000j/11554494.
Additional Manufacturer Narrative
Revised b1 to capture adverse event.

• 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
• MDR Report Key: 11293421
• Report Number: 3007284313-2021-01239
• Device Sequence Number: 3801865
• Product Code: MIH
• UDI-Device Identifier: 00733132610143
• UDI-Public: 00733132610143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2021

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: 12/31/2015
• Device Model Number: PXT231414
• Device Catalogue Number: PXT231414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 01/21/2021; 06/11/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 02/08/2021; 06/15/2021
• Patient Sequence Number: 1
• Patient Age: 87 YR