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

Model Number	RLT261418
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Claudication (2550)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.Images were provided, and an imaging evaluation was performed.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.The imaging evaluation stated the following: approximately 13mm distal to the flow divider the diameter within the ipsilateral limb is ~7mm.There is no evidence of claudication within or distal to the implanted ipsilateral limb.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, claudication (e.G., buttock, lower limb).
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2020 the physician provided films for evaluation.The date of imaging was (b)(6) 2020.It was reported that the patient had claudication in one leg.Information regarding the amount of blood flow through the patient's limb and implanted device was unavailable.The physician reported that the films appeared to show a kink in the gore® excluder® aaa trunk-ipsilateral leg component along the ipsilateral limb.The ipsilateral limb was reported to be located on the patient's right side.It was also reported that the ipsilateral limb appeared to be on the inner curve, and did not appear to have radial force to keep it open.It was suspected that the issue was related to patient anatomy as it reportedly appeared that the device kink may have been caused by aortic remodeling after the initial procedure.No intervention has been scheduled.The patient will be monitored.
Event or Problem Description
It was initially reported that the ipsilateral limb of the gore® excluder® aaa trunk-ipsilateral leg component appeared to be on the inner curve, and did not appear to have radial force to keep it open.This was further clarified by the field sales associate (fsa) that there appeared to be a flow limiting kink on the inner curve of the ipsilateral limb.The fsa further reported that there was no calcification at the site that would cause the kink.An intervention was performed on (b)(6) 2020, to reline the ipsilateral limb in the area of the device kink.An 11mmx29mm gore® viabahn® vbx balloon expandable endoprosthesis was placed in the location of the kink.The kink was successfully treated.There were no blood flow issues noted through the limb.The patient tolerated the intervention.
Additional Manufacturer Narrative
B.5.Event description added.H.6.Conclusion codes remain unchanged.

• 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: 10268530
• Report Number: 3007284313-2020-00173
• Device Sequence Number: 2951582
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 04/28/2022
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• Device Lot Number: 20530700
• 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: 07/13/2020
• Supplement Report FDA Received Date: 07/23/2020
• 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: Other
• Patient Age: 72 YR