MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT231218
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications include metformin and losartan.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), the intended aortic vessel diameter for a 23mm trunk-ipsilateral leg component is 19-21mm.Per ifu, considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with a gore® excluder® aaa endoprosthesis to treat an abdominal aortic aneurysm.On (b)(6) 2018, a post-operative computed tomography scan reportedly revealed a compressed ipsilateral limb.According to the report, the patient¿s abdominal aorta was narrow (measuring approx.18mm in diameter).It was reported that the patient was asymptomatic, but physician opted for re-intervention as a precautionary measure.On (b)(6) 2018, the patient underwent a re-intervention procedure whereby an additional excluder® device was implanted to provide added radial force and ensure distal blood flow.Patency of the ipsilateral limb was preserved, and the patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7935093
• Report Number: 3007284313-2018-00279
• Device Sequence Number: 19417576
• Product Code: MIH
• UDI-Device Identifier: 00733132622351
• UDI-Public: 00733132622351
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2020
• Device Catalogue Number: RLT231218
• Device Lot Number: 16378052
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 69