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

Catalog Number	RMT231214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional concomitant medical products: patient medications: micardis, coumadin, fragenta, furosemide, aspirin, coreg, and potassium chloride.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events which may occur and require intervention include endoleak.
Event or Problem Description
On (b)(6) 2015, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that patient had a persistent type i endoleak.There was aneurysm enlargement (amount is unknown).The physician reintervened on (b)(6) 2019, used aptus anchors and implanted a gore® excluder® aaa aortic extender endoprosthesis (b)(4).The endoleak was not resolved and the physician is taking a wait and watch approach.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: 8371480
• Report Number: 2017233-2019-00101
• Device Sequence Number: 13786288
• Product Code: MIH
• UDI-Device Identifier: 00733132610518
• UDI-Public: 00733132610518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

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: 01/31/2015
• Device Catalogue Number: RMT231214
• Device Lot Number: 10065287
• 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: 02/26/2019
• 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; Required Intervention
• Patient Age: 78 YR