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

Catalog Number	RLT231414
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 (ifu), patients should be counseled as to the possibility of subsequent reinterventions including catheter-based and open surgical conversion.
Event or Problem Description
On (b)(6) 2019 the patient had 5 gore® excluder® aaa endoprosthesis implanted to treat an abdominal aortic aneurysm.On an unknown date it was noted by the physician the a graft collapsed on the proximal portion of the device.On (b)(6) 2019, devices were being explanted and the surgery would be converted to open repair.
Additional Manufacturer Narrative
Updated conclusion code to reflect new incoming information.The patient had the following components explanted along with the rlt231414/18828305, udi: (b)(4) ceb231010a/18366164, udi: (b)(4).Hgb161007a/18679695, udi: (b)(4).Plc271200/20157302, udi: (b)(4).Plc271400/17253686, udi: (b)(4).
Event or Problem Description
On (b)(6) 2019 the patient had five gore® excluder® aaa endoprostheses implanted to treat an abdominal aortic aneurysm.On an unknown date the patient had a ct scan and it was noted by the physician the proximal end of the rlt231414 had collapsed.On (b)(6) 2019, all five gore® excluder® aaa endoprostheses were being explanted and the surgery was converted to open repair.The patient reportedly 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: 8597634
• Report Number: 3007284313-2019-00140
• Device Sequence Number: 2193215
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: 00733132622375
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2019

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: 11/12/2021
• Device Catalogue Number: RLT231414
• Device Lot Number: 18828305
• 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; Not provided
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/10/2019; 06/12/2019
• 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: 58 YR