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

Model Number	PXT231218
Medical Device Problem Codes	Component Incompatible (1108); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that this event was also reported in medwatch(es) #3007284313-2020-00012 and.Details of the event required a separate medwatch submission for the component identified in field(s); as such this medwatch is being submitted.
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment of an abdominal aortic aneurysm measuring approximately 45mm in diameter, and was implanted with gore® excluder® aaa endoprosthesis.In the beginning of (b)(6) 2020, follow-up imaging revealed aneurysm enlargement to approximately 60 mm in diameter and a type ii endoleak from the l4 lumbar artery.Additionally, a proximal type i endoleak was determined along with a type iii endoleak due to component disconnect of the contralateral leg component from the contralateral gate.On (b)(6) 2020, a reintervention was performed and an endurant cuff was placed to treat the proximal type i endoleak, and a contralateral leg component was placed to treat and reline the type iii endoleak.No treatment for the type ii endoleak was performed but future treatment is planned.The type i endoleak was reported to have not been resolved by placement of the endurant cuff.The patient tolerated the procedure.
Additional Manufacturer Narrative
G9: please note that this event was also reported in medwatch(es) #3007284313-2020-00012 and 2017233-2020-00392.Details of the event required a separate medwatch submission for the component identified in field(s) d4 above; as such this medwatch is being submitted.

• 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: 10098773
• Report Number: 2953161-2020-00013
• Device Sequence Number: 3448734
• Product Code: MIH
• UDI-Device Identifier: 00733132610129
• UDI-Public: 00733132610129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/10/2020

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: 11/30/2014
• Device Model Number: PXT231218
• Device Catalogue Number: PXT231218
• Device Lot Number: 9840571
• 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: 05/28/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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; Other
• Patient Age: 82 YR