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

Model Number	PLC121200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that this event was reported in medwatch #: 3007284313-2020-00012.Details of the event required a separate medwatch submission for the contralateral leg component, as such this medwatch is being submitted.Concomitant medical devices: patient medications include but are not limited to: warfarin.(b)(4).
Event or Problem Description
On (b)(6) 2019, this patient underwent treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis.The patient tolerated the procedure.On (b)(6) 2020, the patient was diagnosed with a proximal type i endoleak and a distal type i endoleak associated with the contralateral leg component on the left side.On (b)(6) 2020, the patient underwent reintervention and the left hypogastric artery was coil embolized and covered with an additional contralateral leg component; and proximally a gore® excluder® aortic extender component to extend coverage of the trunk.The physician believes extensive calcium in the neck and the left common iliac artery may have held the graft off the wall and contributed to the endoleaks.Additionally, it was reported that the patient being on warfarin may have been a contributing factor for the endoleaks.The patient tolerated the procedure with the distal type i endoleak having been resolved.Resolution of the proximal type i endoleak was indeterminate and the patient will undergo repeat computed tomography angiography in three weeks.

• 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: 9615524
• Report Number: 3013164176-2020-00006
• Device Sequence Number: 14133608
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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: 03/17/2022
• Device Model Number: PLC121200
• Device Catalogue Number: PLC121200
• Device Lot Number: 20364299
• 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: 01/22/2020
• 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; Required Intervention
• Patient Age: 67 YR