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

Catalog Number CEB231210A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment for and iliac aneurysm with gore® excluder® iliac branch endoprostheses.It was reported the physician had to deploy higher than needed to make room for cannulation into the hypogastric artery, once in place and with the gore® excluder® iliac branch endoprosthesis-internal iliac component hgb device into the vessel (pre-deployed).The physician tried to move the gore® excluder® iliac branch endoprosthesis-iliac branch component (ceb231210a/18595603) device down and he saw the nose cone moving with no device movement.Then he saw what looked like the radiopaque tip of the device moving on the catheter.The clinical specialist then instructed the physician to finish deployment.When the device was taken out you could see the proximal marker (olive tip) moving up and down the catheter.The olive tip was still attached to the catheter.The patient tolerated the procedure with no adverse event.

• 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
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8592837
• MDR Text Key: 145640509
• Report Number: 3013164176-2019-00049
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635290
• UDI-Public: 00733132635290
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2021
• Device Catalogue Number: CEB231210A
• Device Lot Number: 18595603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 98