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

Catalog Number HGB161007A

Device Problem Compatibility Problem (2960)

Patient Problem Aneurysm (1708)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm and a common iliac artery aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system and gore® excluder® iliac branch endoprostheses.During the procedure, it was reported that the internal iliac component was unable to be advanced over the wire into the internal iliac artery.The physician encountered resistance when pulling the catheter back and the undeployed device became detached from the catheter and landed in the sheath.The sheath and the device were withdrawn together from the patient.The broken device was discarded and another internal iliac component was used to complete the procedure successfully.The patient tolerated the procedure.

Manufacturer Narrative

B1, h1: additional/corrected information.

• Brand Name: AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9234818
• MDR Text Key: 168853566
• Report Number: 3013164176-2019-00136
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635313
• UDI-Public: 00733132635313
• 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: 12/10/2019

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: 07/22/2022
• Device Catalogue Number: HGB161007A
• Device Lot Number: 20876447
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 90