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

Catalog Number	PXA260300
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoprosthesis: migration.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with four gore® excluder® aaa endoprostheses featuring c3® delivery system.An aortic extender endoprosthesis was placed on the distal end of a contralateral leg endoprosthesis in the left common iliac artery.The patient tolerated the procedure.On an unknown date in 2016, a follow-up imaging reportedly showed that one of the contralateral leg endoprosthesis in the left common iliac artery migrated approximately 5mm proximally.On an unknown date in (b)(6) 2018, imaging identified the left common iliac artery diameter enlargement.On (b)(6) 2018, an additional procedure was performed to treat the left common iliac artery diameter enlargement.It was reported that the left internal iliac artery was embolized and two contralateral leg endoprostheses were implanted from the left common iliac artery to the left external iliac artery.The patient tolerated the procedure.
Additional Manufacturer Narrative
D11: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pxc201400j/11757612 udi: (b)(4).

• 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: 8241034
• Report Number: 2953161-2019-00006
• Device Sequence Number: 16539822
• Product Code: MIH
• UDI-Device Identifier: 00733132609888
• UDI-Public: 00733132609888
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 02/29/2016
• Device Catalogue Number: PXA260300
• Device Lot Number: 11187479
• 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: 01/11/2019
• Supplement Report FDA Received Date: 01/16/2019
• 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; Other; Required Intervention
• Patient Age: 58 YR