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

Model Number	PLC201400
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/02/2020
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.Images were provided to gore for evaluation and showed the following: one time-point available for evaluation: post-implantation cta dated 2 sep 2020.The contralateral limb appears to end within the aneurysmal portion of the proximal lci, so there is lack of device apposition in the lci.The length from the distal contralateral limb to the left iliac bifurcation appears to be ~5.4cm, by outer curve length.Cannot confirm migration with one time-point.There appears to be 15mm of seal zone in the distal lci with diameters ranging from 12.8mm ¿ 18.7mm.
Event or Problem Description
On september 4, 2020, follow-up images were provided to the field sales associate.The physician reports that the contralateral limb seems to be sitting up a little high and may have migrated proximally.No other issues were reported.On (b)(6) 2020, the patient underwent reintervention and the contralateral side was implanted with an additional contralateral leg component to provide additional coverage to the common iliac artery due to proximal migration of initial graft up within the aneurysm sac.The patient tolerated the procedure with good results.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10590787
• Report Number: 2953161-2020-01023
• Device Sequence Number: 2627389
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 01/30/2020
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/25/2020
• 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