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

Model Number	RMT281216
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/02/2020
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, adverse events with may occur and/or require intervention including, but not limited to, improper component placement.
Event or Problem Description
On (b)(6) 2013, the patient was treated for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2020, the patient underwent revision surgery to treat a type ib endoleak.Plc181400/lot 20382240 was implanted.The physician believes the endoleak was caused by the limb of the original implant not extending far enough into the left iliac artery.The patient tolerated the procedure.
Additional Manufacturer Narrative
Images were returned for evaluation.The imaging evaluation stated: images provided are post-op cta dated (b)(6) 2019.Arterial and delay phase are provided although time between the two phases is ~ 1 minute, contrast difference is minimal by visual assessment.Possible contrast outside of the device on the arterial phase, less prominently visualized on delay phase.There appears to be previous embolization of a lumbar artery.Length from the distal end of the stent graft to the liia appears to measure ~ 38 mm on the left.Length from the distal end of the stent graft to the riia appears to measure ~ 16 mm on the right.There appears to be a possible endoleak of indeterminate origin present, density is better visualized on arterial phase than delay phase.Unable to confirm without a non-contrast phase.Additional devices implanted: pxc121200 lot# 10920198.Pxa280300 lot# 10655318.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (ORIGINAL)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9659829
• Report Number: 2017233-2020-00064
• Device Sequence Number: 3654644
• Product Code: MIH
• UDI-Device Identifier: 00733132610686
• UDI-Public: 00733132610686
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/10/2020

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: 05/31/2015
• Device Model Number: RMT281216
• Device Catalogue Number: RMT281216
• Device Lot Number: 10442129
• 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: 02/03/2020
• Supplement Report FDA Received Date: 03/10/2020
• 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: Required Intervention
• Patient Age: 79 YR