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

Model Number	RLT231216
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), anatomical requirements include infrarenal aortic neck treatment diameter range of 19-32 mm.As reported, the neck diameter range was 15-20mm, although the physician could not say that this caused or contributed to the inability to cannulate the contralateral leg gate.
Event or Problem Description
On (b)(6) 2020 this patient underwent endovascular treatment of an aortic aneurysm using a gore® excluder® aaa endoprostheses.It was reported that after multiple attempts, the contralateral gate was unable to be cannulated.It was decided that an aorto-uni-iliac stent graft procedure would be performed with a femoral-femoral bypass, which was successful.The physician or field sales associate could not find a reason for the contralateral gate being unable to be cannulated, however, it was reported that the patient had a reverse tapered aortic neck with a diameter range of 15mm-20mm, and that the graft had the appearance of looking crimped.No further issues were reported 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: 10192269
• Report Number: 3007284313-2020-00158
• Device Sequence Number: 13674656
• Product Code: MIH
• UDI-Device Identifier: 00733132622344
• UDI-Public: 00733132622344
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 03/25/2022
• Device Model Number: RLT231216
• Device Catalogue Number: RLT231216
• Device Lot Number: 20398360
• 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: 06/24/2020
• 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: Hospitalization; Required Intervention