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

Catalog Number	PXT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the instructions for use (ifu) for the gore® excluder® aaa endoprostheses; adverse events that may occur include, but are not limited to include: vascular spasm or vascular trauma (e.G., ilio-femoral vessel dissection, bleeding, rupture, death), arterial or venous thrombosis and / or pseudoaneurysm.
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm with and was implanted with gore® excluder® aaa endoprostheses.The main body was implanted on the with the placement of the ipsilateral leg on the left side within the left common iliac artery.The procedure was finished with no evidence of endoleak or dissection reported.In (b)(6) 2018, the patient underwent follow-up examination which revealed a dissection of the left external iliac artery.The cause of the dissection was unknown, but the dissection had not been observed on the previous follow-up computed tomography scans and it occurred outside the treated region.The physician stated it was not a iatrogenic dissection.The physician decided to take a wait-and-see approach for the dissection.On (b)(6) 2019, the patient presented to the hospital complaining of gluteal muscle claudication.It was revealed that abi (ankle brachial pressure index) had decreased (abi = 0.4), and the ipsilateral leg and the left external iliac artery showed stenosis due to thrombosis.The patient emergently underwent re-intervention for treatment of the stenosis.Percutaneous transluminal angioplasty (pta) was performed in the stenosed region.A balloon-expandable viabahn endoprosthesis was implanted in the left external iliac artery, and a contralateral leg component was implanted bridging the pxt261416 and the viabahn.The blood flow was restored.The patient tolerated the procedure.The physician stated that the dissection of the left external iliac artery was contributed to the stenosis.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8505344
• Report Number: 2953161-2019-00032
• Device Sequence Number: 16519302
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: 01/31/2016
• Device Catalogue Number: PXT261416
• Device Lot Number: 11112651
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 89 YR