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

Catalog Number CEB231410

Device Problem Disconnection (1171)

Patient Problem Aneurysm (1708)

Event Date 10/21/2021

Event Type  Injury  

Manufacturer Narrative

The gore® excluder® aaa endoprosthesis is being reported separately.

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient underwent endovascular treatment of an iliac artery aneurysm which included the use of a gore® excluder® iliac branch endoprosthesis and a gore® excluder® aaa contralateral leg endoprosthesis as bridging limb.On an unknown date prior or equal to (b)(6) 2021 a type iii endoleak and aneurysm expansion of unknown amount due to dislocation of the right bridging limb from the gore® excluder® iliac branch endoprosthesis was discovered by imaging.The patient was not well enough to undergo any treatment.The case is ongoing.

Manufacturer Narrative

H6: component code added.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12774102
• MDR Text Key: 283427842
• Report Number: 2953161-2021-01101
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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 Expiration Date: 02/07/2020
• Device Catalogue Number: CEB231410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male