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

Model Number	RMT231418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxc141400/11636609 udi: (b)(4).Concomitant medical products-patient medications include metamucil, propranolol, losartan, loped, vitamin b, glucosamine, and calcium.The review of the manufacturing paperwork verified that these lots met all pre-release specifications.According to the conformable gore® excluder® aaa endoprosthesis instructions for use, adverse events which may occur and require intervention include endoleak and aneurysm enlargement.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Images were sent to gore imaging services for evaluation.Per the evaluation the proximal implanted endograft appears to be well apposed for approximately 11mm.No contrast is visualized outside the implanted endograft.No contrast is visualized within the proximal aneurismal sac.There is approximately 28mm of apposition within the contra lateral gate.There appears to be a total of 3cm of implanted endografts within the common iliac arteries.The distal right ipsilateral limb appears to be within a somewhat aneurismal section of the vessel but no contrast is visualized outside the implanted graft.There is approximately 35mm from the right ipsilateral limb to the hypogastric origin.There are densities consistent with type 2 endoleaks visualized within the abdominal aneurism sac during the ct¿s delayed phase.
Event or Problem Description
On (b)(6) 2013, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.On an unknown date, a follow-up computed tomography scan reportedly revealed a type ii endoleak with aneurysm sac enlargement.On (b)(6) 2020, there was a reintervention and the physician coiled several accessory arteries then implanted a gore® excluder® aaa contralateral leg endoprosthesis in the right common iliac artery to extend the already implanted device.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
Correction upon further investigation, it has been determined there is no allegation of deficiency on the pxc141400/11636609 device.This device will be removed from the event.

• 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: 9954730
• Report Number: 2017233-2020-00243
• Device Sequence Number: 2438103
• Product Code: MIH
• UDI-Device Identifier: 00733132610570
• UDI-Public: 00733132610570
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 08/31/2020

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: 04/30/2016
• Device Model Number: RMT231418
• Device Catalogue Number: RMT231418
• Device Lot Number: 11518766
• 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: 04/13/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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
• Patient Weight: 66