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

Catalog Number	RLT261412
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to device occlusions.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 date a patient underwent treatment of an abdominal aortic and common iliac artery aneurysm with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses with good angiographic results.On (b)(6) 2019 follow-up images revealed the left side, ipsilateral leg of the trunk-ipsilateral leg component was being compressed by the proximal end of the ibe component in the distal aorta.This was thought to be due to a tight distal bifurcation.The patient was asymptomatic and had femoral pulses.However the surgeon was concerned about limb thrombosis and planned to reinforce the narrowed limb with a balloon expandable stent.On (b)(6) 2019 a reintervention took place whereby a bare metal balloon expandable stent was implanted and dilated to 12 mm.The angiographic outcome was good.
Additional Manufacturer Narrative
Section d: updated.H.6.Results code 1: 213: a correction was made with regard to the device which was compressed.This device: rlt261412 lot# 20236273 udi: (b)(4) also met pre-release specifications.H.6.Conclusion code 1: 22: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to device occlusions.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9060654
• Report Number: 3013164176-2019-00115
• Device Sequence Number: 19643983
• Product Code: MIH
• UDI-Device Identifier: 00733132618743
• UDI-Public: 00733132618743
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 09/19/2019

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: 02/13/2022
• Device Catalogue Number: RLT261412
• Device Lot Number: 20236273
• 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: 09/15/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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: 79 YR