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

Model Number CEB231410A

Device Problems Complete Blockage (1094); Unintended Movement (3026)

Patient Problem Thrombus (2101)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, component migration and occlusion of device or native vessel.

Event Description

On (b)(6) 2020, the patient was treated for left common iliac aneurysm.A gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprosthesis were implanted.The procedure was successful, but it was later seen that a separation had occurred between the two devices.In addition, the iliac had completely clotted off.A reintervention is planned.Review of returned images was performed.The imaging evaluation stated: there appears to be significant tortuosity within aorta, right and left common iliac arteries.Tortuosity significance is greatest in l>r > aorta.No procedural or post implant images were provided.As no additional images were provided, unable to determine how devices were implanted to accommodate the anatomical curvature once the stiff wires were removed.

Manufacturer Narrative

G3/4: added pma/510(k) number p020004.Images were returned for evaluation.The evaluation stated: there appears to be significant tortuosity within aorta, right and left common iliac arteries.Tortuosity significance is greatest in l>r > aorta.No procedural or post implant images were provided.As no additional images were provided, unable to determine how devices were implanted to accommodate the anatomical curvature once the stiff wires were removed.

• Brand Name: GORE EXCLUDER ILIAC BRANCH 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: 10992578
• MDR Text Key: 220952138
• Report Number: 3013164176-2020-01089
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635306
• UDI-Public: 00733132635306
• 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: 04/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: CEB231410A
• Device Catalogue Number: CEB231410A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 04/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR