MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number VBJR052502A

Device Problems Device Damaged by Another Device (2915); Activation Failure (3270)

Patient Problem Perforation (2001)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.Instructions for use (ifu) for gore® viabahn® endoprosthesis with heparin bioactive surface warnings section states, w.L.Gore & associates has insufficient clinical and experimental data regarding the use of the gore® viabahn® endoprosthesis within stents or stent grafts (other than the gore® viabahn® endoprosthesis with heparin bioactive surface or the gore® viabahn® endoprosthesis) that have been implanted for less than 30 days.Other devices implanted for less than 30 days may interfere with the deployment of the gore® viabahn® endoprosthesis resulting in deployment failure or other device malfunctions.

Event Description

The following was reported to gore: patient presented with thrombosis in superficial femoral artery (sfa).A zilver ptx stent was deployed first but blood flow was not re-established.Consequently, a gore® viabahn® endoprosthesis was advanced in order to cover the stenotic lesion.As reported, the zilver ptx stent and the viabahn device were at least 2 cm apart in the native vessel with no overlap.During deployment of the viabahn device, the device expanded about 2 cm when the deployment line became stuck.Further deployment was not possible.A longer sheath was inserted and attempts were made to capture the partially expanded viabahn device.In the process, the viabahn deployment line became entangled with the zilver ptx stent.As a result, a cut down was performed in the patient's right sfa.The viabahn device was cut into two sections and removed along with the zilver ptx stent.The artery was repaired and patient was sent to recovery.

Manufacturer Narrative

Device was released and returned from user facility.Field was populated.Code 213: engineering evaluation state the entire device was returned.The deployment knob was cut and separated from the deployment hub.About 2.5cm of deployment line was connected to the constrained end of the endoprosthesis at the transition.The distal shaft upon which the endoprosthesis is mounted, appeared to have been cut approximately 20.5cm from the transition.The endoprosthesis was cut along with the distal shaft, approximately 5cm from the tip.The endoprosthesis was partially expanded 1cm at the tip end.The inner braided constraining line was deployed approximately 1cm.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8117731
• MDR Text Key: 128856719
• Report Number: 2017233-2018-00725
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623938
• UDI-Public: 00733132623938
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Catalogue Number: VBJR052502A
• Device Lot Number: 18390396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZILVER PTX STENT, GUIDEWIRE, SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 82