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

Catalog Number	PXC121000
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Per the gore® excluder aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoprosthesis component migration, endoleak, and aneurysm enlargement.Users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
On (b)(6) 2013, the patient was implanted with two gore® excluder aaa endoprostheses to treat an abdominal aortic aneurysm.During the procedure, a type ii endoleak was reportedly identified.The physician decided to take a wait-and-watch approach in regard to the type ii endoleak and completed the procedure.On an unknown date, it was reported that the aneurysm was enlarged due to the type ii endoleak originating from the vasa vasorum.A distal type i endoleak secondary to proximal migration of the contralateral leg component (b)(4) on the right side was also reportedly identified.On (b)(6) 2018, the patient underwent a re-intervention procedure whereby the right internal iliac artery was coil-embolized, and an additional excluder® contralateral leg component was implanted distally on the right side to treat the distal type i endoleak.The endoleak was resolved.During the same procedure, the physician reportedly made an attempt to approach the vasa vasorum through the aneurysm to treat the type ii endoleak, but the approach was unsuccessful.The physician aborted treatment of the type ii endoleak and will continue to monitor the patient.The patient tolerated the procedure.

• 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: 8208645
• Report Number: 2953161-2019-00001
• Device Sequence Number: 1670071
• Product Code: MIH
• UDI-Device Identifier: 00733132609918
• UDI-Public: 00733132609918
• 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
• Report Date (Section B): 12/10/2018

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: 11/30/2015
• Device Catalogue Number: PXC121000
• Device Lot Number: 10933616
• 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: 01/02/2019
• 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; Required Intervention
• Patient Age: 73 YR