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

Model Number	VBH130502A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.
Event or Problem Description
The following was reported to gore: the patient presented for upper arm fistula repair.The gore® viabahn® endoprosthesis was advanced into position and the deployment line pulled.While pulling the deployment line, the deployment line broke.The doctor was able to grasp the partially deployed device with a pair of hemostats and pulled it out.When out of the patient the doctor observed the tip of the catheter was still in the patient on the wire.The tip was removed with the wire.
Additional Manufacturer Narrative
Corrected data: h6.Results code 2.H6.Conclusions code 1.Additional manufacturer narrative: examination of the returned device revealed the following: the entire device was returned.The deployment line was caught on a damaged stent, and tangled such that it could not be measured.The distal shaft, upon which the endoprosthesis is mounted, was broken into two sections.Approximately 5cm of the distal shaft was attached to the delivery catheter.There was a 3cm damaged portion which appeared compressed and had exposed braided wire.The other section of the distal shaft measured approximately 3 cm and is attached to the distal tip.The endoprosthesis was damaged and had outwardly flared struts throughout the length.The stent wire delaminated from the graft.Approximately 1 cm of the endoprosthesis was expanded.The remainder of the endoprosthesis not damaged, or expanded was constrained by the deployment line and measured approximately 2.6 cm.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9541186
• Report Number: 2017233-2020-00005
• Device Sequence Number: 2282993
• Product Code: PFV
• UDI-Device Identifier: 00733132623280
• UDI-Public: 00733132623280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2022
• Device Model Number: VBH130502A
• Device Catalogue Number: VBH130502A
• Device Lot Number: 20458143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1