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

Catalog Number VBC130502

Device Problems Material Fragmentation (1261); Separation Failure (2547); Difficult or Delayed Activation (2577)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to gore that a 13mm x 5cm gore® viabahn® endoprothesis was to be implanted for treatment of dissection of the right common iliac artery.During deployment, a resistance was reportedly felt on pulling the deployment line.The device was able to deploy and expand completely with extra force.However, the deployment line got stuck on the nitinol stent to release from the catheter.The physician ever attempted to release the deployment line by using a catheter and a balloon, but all failed.Finally the physician inserted a cook dchn puncture needle to cut the deployment line and the catheter was able to retract out of the patient.About 10cm deployment line being connected to the viabahn device was left inside the patient.The physician concerned the fragment of deployment line inside the patient might cause a thrombosis of the common iliac artery, a bare stent was implanted to pin the fragment of deployment line against the vessel wall.

Manufacturer Narrative

Results code 2 updated.Conclusion code 1 updated.The device was returned for engineering investigation and the following observations were made: the endoprosthesis and deployment knob were not returned.A deployment line was returned which measured approximately 100 cm long with 2 fibers extending an additional 26.5 and 47 cm.There appears to be some damage to the transition adjacent to the distal shaft upon which the endoprosthesis was mounted.The remainder of the delivery catheter appeared unremarkable.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: 7913082
• MDR Text Key: 121861892
• Report Number: 2017233-2018-00573
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132614745
• UDI-Public: 00733132614745
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

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: 08/10/2020
• Device Catalogue Number: VBC130502
• Device Lot Number: 17454274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 65