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

Catalog Number VBCR081001A

Device Problems Partial Blockage (1065); Failure to Unfold or Unwrap (1669); Detachment of Device or Device Component (2907)

Patient Problem Stenosis (2263)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.Reference voluntary medwatch mw5087289.

Event Description

The following was reported to gore: during deployment of the gore® viabahn® endoprosthesis, resistance was met pulling back the deployment line.The tech stopped immediately and informed the doctor.The doctor attempted to continue deployment but was unable.After multiple attempts to deploy the stent, the doctor pulled the catheter out, leaving behind a partially deployed gore® viabahn® endoprosthesis.The patient was sent out 911 to christiana for emergent dialysis catheter insertion and may undergo surgery to remove the gore® viabahn® endoprosthesis.That plan has not been finalized.

Event Description

The following was reported to gore: during deployment of the gore® viabahn® endoprosthesis, resistance was met pulling back the deployment line.The tech stopped immediately and informed the doctor.The doctor attempted to continue deployment but was unable.After multiple attempts to deploy the stent, the doctor pulled the catheter out, leaving behind a partially deployed gore® viabahn® endoprosthesis.The patient was sent to christiana hospital for emergent dialysis catheter insertion and surgery to remove the gore® viabahn® endoprosthesis.

Manufacturer Narrative

Additional manufacturer narrative: examination of the returned device revealed the following: the delivery catheter was returned; the distal tip was no longer attached to the delivery catheter and was not returned; there was columnar failure of approximately 4cm at approximately 54cm from the hub; the delivery catheter also appeared stretched at this location; the delivery catheter also appeared stretched at 61 cm from the hub and was approximately 6cm long; the distal shaft, upon which the endoprosthesis was mounted, had frayed pebax at the tip end; there was a kink in the distal shaft at the transition.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.All information has been placed on file for tracking and trending.Corrected data: h6: results code 2.H6: conclusions code 1.

Manufacturer Narrative

Additional manufacturer narrative: the actual device was returned to gore on 07/30/2019.Examination of the returned device revealed the following: the device was returned in three sections: the first section measured approximately 5cm; approximately 1 cm was still constrained by the braided constraining line; there were four single fibers coming from the braided constraining line attached to the endoprosthesis; the single fibers measured approximately 8 cm, 1cm, and two measured 0.3cm; this section of the endoprosthesis had a hole in its body that traversed about 3 stent wire apices; the second section measured about 1.5 cm.; the stent wire and body tape appeared to be delaminating from the graft; there was a cut at one end of the second section of endoprosthesis; the endoprosthesis appeared to have been cut.The second section had tissue attached to it; there appeared to be a surgical staple in the tissue, the surgical staple was not evaluated as it is not a gore device.The third section measured about 3 cm.; one end of the endoprosthesis was within a gore® acuseal vascular graft, the synthetic graft appears to be sutured to the tissue that surrounds it; the other end is encased in tissue and was not evaluated.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Corrected data: h3.Device evaluated by manufacturer?.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8749480
• MDR Text Key: 149679673
• Report Number: 2017233-2019-00485
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623525
• UDI-Public: 00733132623525
• 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,Followup,Followup,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Catalogue Number: VBCR081001A
• Device Lot Number: 20555463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 64