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

Model Number VBJR051002A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.The engineering investigation is ongoing.

Event Description

The following was reported by the fsa: on (b)(6) 2020 the patient presented occlusion in the superficial artery.When deploying the gore® viabahn® endoprosthesis the deployment line came out and the physician commented the deployment line 'looked torn'.The fsa reported that the doctor appeared to aggressively pull the deployment line and may have contributed to the deployment line break.When the physician went to pull the catheter out of the patient he realized the stent was not fully deployed and had inadvertently pulled the gore® viabahn® endoprosthesis back through the vessel and into the sheath.The physician was able to remove the device and sheath in tandem.A 5mm x 10cm gore® viabahn® endoprosthesis was successfully deploy to complete the procedure.The patient tolerated the procedure and is doing well.

Manufacturer Narrative

The engineering evaluation is as follows: the endoprosthesis, delivery catheter, and constraining sleeve were returned.The endoprosthesis was damaged and had outwardly flared struts in the first and second strut rows near the straight cut end of the endoprosthesis.The endoprosthesis was expanded approximately 0.5 cm near the tip end of the device.The remainder of the endoprosthesis was still constrained.There was a 2 cm and a 0.5 cm single fiber coming off of the constraining sleeve where deployment appears to have stopped.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.Engineering evaluation conclusion is inconclusive as it relates to the event description.The reported issue codes are representative of this event.Based on the evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.H3, device evaluated by manufacturer - updated to yes.H6, method code 2 - updated to 10.H6, results code 2 - updated to 213.H6, conclusion code - updated to 4315.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9819328
• MDR Text Key: 197656713
• Report Number: 2017233-2020-00174
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623914
• UDI-Public: 00733132623914
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: VBJR051002A
• Device Catalogue Number: VBJR051002A
• Device Lot Number: 20789268
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 95 YR