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

Catalog Number	PLC181400
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report, which are captured in manufacturer report #3007284313-2019-00154, are as follows: item #rlt351416/lot #14258082/ (b)(4), item #pxl161407/lot #14432048/ (b)(4).The device remains implanted, so evaluation of the actual device was unable to be completed.Images are available, and an imaging evaluation is in progress.The review of the manufacturing paperwork verified that the lots met all pre-release specifications.Results pending completion of imaging evaluation.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, arterial or venous thrombosis.
Event or Problem Description
On (b)(6) 2015 the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that on (b)(6) 2019 the patient presented to the emergency room with low cardiac output due to hypovolemia.It was determined that the patient had a type iii endoleak, and subsequent abdominal aortic aneurysm rupture.Reportedly the iliac extender component had become separated from the ipsilateral leg of the trunk-ipsilateral leg component.It was also reported that the contralateral leg component, located on the patient's left side, was thrombosed.It was noted that the contralateral leg component appeared to be kinked.A femoral to femoral bypass was performed to treat the aneurysm rupture.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
The imaging evaluation stated the following: the length from the lowest renal to the proximal end of the device appears to be ~13mm.The diameters distal to the renal appear to range from 31mm (within device) ¿ 34mm.There appears to be significant thrombus distal to the lowest renal.The contralateral limb of the device appears to be occluded.The distal end of the contralateral gate appears to land near an angle within the infrarenal aorta.Received one time point for review.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, arterial or venous thrombosis, and endoprosthesis occlusion.

• 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: 8638736
• Report Number: 3007284313-2019-00155
• Device Sequence Number: 13908840
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: 00733132618699
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: 03/03/2018
• Device Catalogue Number: PLC181400
• Device Lot Number: 13629860
• 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: 05/23/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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: MEDICATIONS: NORVASC, CYMBALTA, COLACE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR