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

Catalog Number	PXT231412
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak.
Event or Problem Description
On (b)(6) 2008, this patient underwent endovascular repair of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On (b)(6) 2019, computed tomographic images were read that showed an apparent type iii disconnect endoleak between the trunk-ipsilateral leg component and the contralateral leg component.On (b)(6) 2019, a reintervention occurred whereby another contralateral leg component (plc161000) was implanted to repair the type iii disconnect endoleak.Final angiography confirmed the endoleak was resolved.The patient was discharged to home on (b)(6) 2019.

• 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: 8731190
• Report Number: 2017233-2019-00457
• Device Sequence Number: 2572997
• Product Code: MIH
• UDI-Device Identifier: 00733132610136
• UDI-Public: 00733132610136
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 05/31/2011
• Device Catalogue Number: PXT231412
• Device Lot Number: 05983021
• 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: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6) 2008: PXC141200/06026366
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR