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

Model Number PLC141400

Device Problems Complete Blockage (1094); Collapse (1099)

Patient Problem Aneurysm (1708)

Event Date 09/08/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with three gore® excluder® aaa endoprosthesis featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2020, follow-up imaging determined an occlusion of the contralateral limb.Imaging showed the contralateral limb at the level of the bifurcation appeared compressed and crushed.A reintervention is planned, yet not yet scheduled wherein the physician plans to lyse the patient and reline the limb.

Manufacturer Narrative

Images were provided to gore and evaluation showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2020.Aortic diameter, post implantation at the bifurcation, appears to be 18mm.Flow lumen diameter at the bifurcation on this time point appears to be ~11mm.The contralateral limb appears to be occluded beginning at the level of the flow divider and extending to the distal end of the limb in the lci.The contralateral limb appears to be compressed at the level of the aortic bifurcation.Contrast appears to reconstitute distal to the end of the contralateral limb in the lci.

Event Description

On (b)(6) 2020, the patient underwent reintervention and an additional contralateral leg component was implanted to reline the occluded limb.Agioplasty of the bifurcation was performed with two 10mm x 40mm kissing balloons.The patient tolerated the procedure with good results.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10628025
• MDR Text Key: 209820821
• Report Number: 3013164176-2020-01051
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: 00733132618651
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2022
• Device Model Number: PLC141400
• Device Catalogue Number: PLC141400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 10/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 75 YR