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

Model Number HGB161207A

Device Problem Obstruction of Flow (2423)

Patient Problems Pain (1994); Thrombus (2101)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and, therefore, was not available for direct analysis by gore.Per the gore® excluder® iliac branch endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, occlusion of device or native vessel.

Event Description

On (b)(6) 2020, a patient underwent endovascular treatment of a right common iliac artery aneurysm using gore® excluder® aaa and iliac branch endoprostheses.An iliac branch component was implanted on the right side, and two internal iliac components were implanted in the right internal iliac artery.The patient tolerated the procedure.On an unknown date in 2020, the patient presented for follow-up examination with buttock pain.A computed tomography scan was performed, and thrombus occlusion of the internal iliac components was reportedly observed.The physician suspected that a contralateral limb used as a bridging device during the procedure may have been deployed at a slant, which may have partially obstructed the proximal end of the internal iliac component.No treatment was performed for the occlusion, and the physician will continue to monitor the patient.

• 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
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11163817
• MDR Text Key: 226595874
• Report Number: 3013164176-2021-01107
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635320
• UDI-Public: 00733132635320
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

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: 01/02/2023
• Device Model Number: HGB161207A
• Device Catalogue Number: HGB161207A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/13/2021
• Date Device Manufactured: 01/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other