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

Catalog Number	RMT261416
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Imaging evaluation results: ct images dated (b)(6) 2018 were received by gore from the facility and an imaging evaluation was performed.Centerline reconstruction illustrated what appeared to be 14mm of proximal seal.There appeared to be contrast pooling outside of the device in the proximal neck area, consistent with a proximal type ia endoleak.Axial image illustrated contrast pooling in the aneurysmal sac.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.Users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
On (b)(6) 2014, the patient was implanted with three gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.On (b)(6) 2018, a computed tomography (ct) scan reportedly revealed a suspected proximal type i endoleak contributing to aneurysm growth (amount not reported).On (b)(6) 2018, a follow-up angiograph was performed.The physician reportedly concluded the endoleak was a type ii from two lumbar pairs and a possible small accessory renal artery.He elected to forgo any intervention, and has referred the patient to interventional radiology for translumbar approach embolization.

• 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: 8197378
• Report Number: 2017233-2018-00799
• Device Sequence Number: 2261447
• Product Code: MIH
• UDI-Device Identifier: 00733132610648
• UDI-Public: 00733132610648
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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: 09/30/2016
• Device Catalogue Number: RMT261416
• Device Lot Number: 11975551
• 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: 12/26/2018
• 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: 83 YR