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

Catalog Number	PXC141000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Images were sent to gore imaging services for evaluation.Per the evaluation there appears to be an unknown density that is visible on the non con, arterial and delayed ct.Unable to confirm if there is contrast outside of the implanted device.Received one time-point for review.Unable to determine aneurysmal growth.(b)(4).
Event or Problem Description
On (b)(6) 2015, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that follow up computed tomography (ct) dated (b)(6) 2019, revealed the patient had a possible proximal type i endoleak or a type iii endoleak with component disconnection.It is unknown if there is aneurysm sac enlargement.The event is ongoing.

• 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: 9165810
• Report Number: 2953161-2019-00057
• Device Sequence Number: 16792223
• Product Code: MIH
• UDI-Device Identifier: 00733132609949
• UDI-Public: 00733132609949
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: 12/31/2017
• Device Catalogue Number: PXC141000
• Device Lot Number: 13416341
• 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: 10/08/2019
• 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
• Patient Age: 84 YR