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

Catalog Number	RLT231212
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note: it is unknown which gore devices were occluded in this event.Therefore the following gore® excluder® devices have also been included in this report: - pxc121000/14128097; - pxl161007/14110314; - pxl161007/14110315.A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to occlusion of device or native vessel.
Event or Problem Description
On (b)(6) 2015, the patient was implanted with four gore® excluder® aaa endoprostheses.On (b)(6) 2016, the patient was implanted with a bare metal stent in the right external iliac artery to treat vessel occlusion distal to the previously implanted stent graft.On an unknown date, additional non-gore manufactured stents were placed on the right side, extending from the right common femoral artery down to the superficial femoral artery (sfa).On (b)(6) 2018, the patient presented to the facility with right leg ischemia.Follow-up imaging reportedly showed complete stent occlusion from the flow divider through the right sfa.On the same day, the patient underwent a re-intervention procedure whereby a cut-down was performed distal to the stent graft system, and the length of the graft was de-clotted using balloon angioplasty (fogarty catheters).Collateralization and flow to the right foot reportedly was also achieved during the procedure.Device patency was restored, 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: 7827461
• Report Number: 2017233-2018-00522
• Device Sequence Number: 19284753
• Product Code: MIH
• UDI-Device Identifier: 00733132622320
• UDI-Public: 00733132622320
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2018
• Device Catalogue Number: RLT231212
• Device Lot Number: 13814461
• 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: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT MEDICATIONS INCLUDE ASPIRIN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 54