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

Catalog Number	PLC231400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.Further information was requested but was not available.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to occlusion of device or native vessel.Additionally, the ifu states: do not cover significant renal or mesenteric arteries with the endoprosthesis.Vessel occlusion may occur.
Event or Problem Description
On (b)(6) 2018 a patient was undergoing treatment of an abdominal aortic aneurysm measuring 59.3mm with a gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprostheses.It was reported that during the initial procedure a left internal iliac artery was occluded.No treatment was required.The physician decided to monitor the patient.The patient tolerated the procedure and discharged from the hospital on (b)(6) 2018.
Additional Manufacturer Narrative
Additional information: b5: event description.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states: additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Key anatomic elements that may affect successful exclusion of the aneurysm include significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.Irregular calcium and / or plaque may compromise the fixation and sealing of the implantation sites.
Event or Problem Description
It was reported that during the initial procedure a left internal iliac artery was occluded.According to the information reported, the occlusion was related with a device used in the left common iliac artery.Reportedly, there was known calcified atherosclerotic disease involving common and internal iliac arteries bilaterally at baseline.No treatment was required.There was never a concern with the occlusion as there was filling via collaterals from the right side.The physician decided to monitor the patient.On may 22, 2019, a follow up imaging confirmed that there was no concern about the left internal iliac artery.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8755747
• Report Number: 3013164176-2019-00075
• Device Sequence Number: 14052942
• Product Code: MIH
• UDI-Device Identifier: 00733132618583
• UDI-Public: 00733132618583
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 07/16/2021
• Device Catalogue Number: PLC231400
• Device Lot Number: 18364139
• 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: 07/02/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: 87 YR
• Patient Weight: 109