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

Catalog Number	VBCR070501A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records indicated the device met pre-release specifications.
Event or Problem Description
The following was reported to gore by the customer: the dialysis patient was being treated for a vein stenosis.The gore® viabahn® endoprosthesis was advanced on a benson.035 wire to the target location and deployed without incident.During removal, the doctor reported a slight resistance.When the catheter was removed, the doctor observed that the tip and part of the shaft had broken off and were still on the wire.The tip and shaft were removed separately.The doctor reported the patient is fine.
Additional Manufacturer Narrative
Examination of the returned device revealed the following: the deployment line, deployment knob, and delivery catheter were returned; the deployment knob was not attached at the hub; the deployment line was fully intact and measured 113 cm; the distal shaft was separated from the transition; the distal shaft appeared to be cut the correct length; the end of the distal shaft appeared to have some missing pebax and was frayed; the remainder of the device appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.All information has been placed on file for use in tracking and trending.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7803370
• Report Number: 2017233-2018-00511
• Device Sequence Number: 16621482
• Product Code: PFV
• UDI-Device Identifier: 00733132623433
• UDI-Public: 00733132623433
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 09/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2021
• Device Catalogue Number: VBCR070501A
• Device Lot Number: 18231845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/25/2018; 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 63