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

Catalog Number	PXT231414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Images were sent to gore imaging services for evaluation.Per the evaluation computed tomography images dated (b)(6) 2018, there is contrast visualized pooling in the aneurysmal sac, contrast of unknown origin.The max diameter appears to be 72.2mm x 82.9mm.Patent lumbar arteries with contrast being visualized in the aneurysmal sac.This would be consistent with a type ii endoleak.Centerline reconstruction illustrating what appears to be 14mm of seal in the left common iliac artery (lci).However, reader did not visualize a distal type i endoleak.(b)(4).
Event or Problem Description
On (b)(6) 2012, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that computed tomography (ct) images dated (b)(6) 2018, revealed a possible type ii endoleak.There is aneurysm sac enlargement (max diameter appears to be 72.2mm x 82.9mm) exact amount is unknown.No reintervention is planned at this time, the physician is taking a wait and watch approach.
Additional Manufacturer Narrative
Event has been deemed non reportable.Review of the event determined this event to be non-reportable.This medwatch will be retracted.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8297331
• Report Number: 2017233-2019-00055
• Device Sequence Number: 1946758
• Product Code: MIH
• UDI-Device Identifier: 00733132610143
• UDI-Public: 00733132610143
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 09/30/2013
• Device Catalogue Number: PXT231414
• Device Lot Number: 8457987
• 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: 02/01/2019
• Supplement Report FDA Received Date: 02/27/2019
• 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: Hospitalization