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

Catalog Number	VBH100502A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.Examination of the returned device revealed the following: the deployment knob, deployment line, and the delivery catheter were returned; the deployment line was fully intact though it appeared to have been broken as there were two single fibers on the end of the deployment line; the deployment line was approximately 170cm including the single fibers which were 10cm and 17cm; the remainder of the device appeared unremarkable.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 use in tracking and trending.
Event or Problem Description
The following was reported to gore: the av/dialysis patient presented for central venous and cephalic arch stenosis treatment.The gore® viabahn® endoprosthesis (viabahn) was advanced to the treatment site in the cephalic arch and deployed without issue.However, the deployment line remained attached to the viabahn.The doctor, on a separate wire, advanced a 10x4 mustang¿ balloon into the viabahn and inflated it to full size.This fixated the viabahn allowing the doctor to pull the deployment line while his assistant pushed on the balloon.The combination of simultaneously pushing the balloon and pulling the deployment line freed the deployment line.The deployment line was removed from the patient.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional manufacturer narrative: examination of the returned device revealed the following: the deployment knob, deployment line, and the delivery catheter were returned; the deployment line was fully intact though it appeared to have been broken as there were two single fibers on the end of the deployment line; the deployment line was approximately 170cm including the single fibers which were 10cm and 17cm; the remainder of the device appeared unremarkable.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: 8817710
• Report Number: 2017233-2019-00546
• Device Sequence Number: 343442
• Product Code: PFV
• UDI-Device Identifier: 00733132623211
• UDI-Public: 00733132623211
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 05/27/2020
• Device Catalogue Number: VBH100502A
• Device Lot Number: 16561039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• 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: 07/23/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR