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

Model Number HGB161407A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

According to the gore® excluder®iliac branch endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoprosthesis occlusions.

Event Description

The following information was reported to gore: on (b)(6)2020, this patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprosthesis an excluder and ibe were placed to repair the abdominal aortic aneurysm and iliac artery aneurysm.On or about (b)(6) 2021, computed tomography image revealed occlusion of the internal iliac component in the left internal iliac artery.The patient has no subjective symptoms.The patient will be monitored.The physician stated that it might have occluded from around the tortuous part in the middle of the left internal iliac artery.

Manufacturer Narrative

H6: results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Manufacturer Narrative

Per md174050, this event is reportable to usa (ref: (b)(4)).Added section g3/g4, h1/h2, h6 conclusion code, health effect clinical/impact code & component code.H6: conclusion code 1: 22: according to the gore® excluder®iliac branch endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoprosthesis occlusions.H6: results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11251937
• MDR Text Key: 229838457
• Report Number: 3013164176-2021-01110
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635337
• UDI-Public: 00733132635337
• 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
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

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: 06/26/2023
• Device Model Number: HGB161407A
• Device Catalogue Number: HGB161407A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 02/03/2021; 12/27/2021
• Supplement Dates FDA Received: 04/08/2021; 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Male