MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number JHJR080502J

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2020, a patient underwent endovascular treatment due to an abdominal aortic aneurysm and a chimney technique was utilized.It was planned to implant a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) in the superior mesenteric artery (sma) as a chimney stent graft.The viabahn device was first advanced into the sma, then a non-gore aortic stent graft was deployed in the abdominal aorta.Next, the physician started deployment of the viabahn device in the sma.After a section of the viabahn device was deployed, the deployment was not able to be continued.The deployment knob was pulled further, and the deployment line broke.The partially expanded viabahn device was removed with a sheath from the patient's body.A new, same sized viabahn device was successfully implanted in the sma to complete the procedure.The patient tolerated the procedure.As reported, the physician stated it was unlikely bowstringing occurred because the anatomy was relatively straightened during the deployment.

Manufacturer Narrative

A2 - patient age/dob was requested but not made available.A3 - patient gender was requested but not made available.A4- patient weight was requested but not made available.The engineering evaluation state: the manufacturing records were reviewed, and the device lot met all pre-release specifications.The complaint of partial deployment with a broken deployment line is confirmed.The ultimate cause of the broken deployment line cannot be established, but a possible misuse has been identified.The reasonably foreseeable misuse identified, forcefully pulling the deployment line when resistance is encountered, is considered possible, but this potential misuse cannot be confirmed with the complaint information that was made available.G2 and g4 - additional checks made.

Manufacturer Narrative

H6: health effect impact code added.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11119634
• MDR Text Key: 229327078
• Report Number: 2017233-2021-01577
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Catalogue Number: JHJR080502J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1