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

Model Number	VBJR061502A
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.
Event or Problem Description
The following was reported to gore: the patient presented for occluded left leg sfa repair.The doctor used an up-and-over approach to the lesion.The device was advanced into place.When the deployment line was pulled, it broke leaving the gore® viabahn® endoprosthesis partially deployed.The fsa reported the deployment line, at the break, appeared frayed.The doctor cut the catheter longitudinally, making like a peel-away sheath, located the broken deployment line and completed the device deployment by pulling the remaining deployment line.
Additional Manufacturer Narrative
Corrected data: d10.Device available for evaluation? (do not send to fda).D10.Returned to manufacturer on: (mm/dd/yyyy).H3.Device evaluated by manufacturer? h6.Results code 1.Additional manufacturing narrative: examination of the returned device revealed the following: the deployment knob, deployment line, and delivery catheter were returned.There was approximately 189 cm of deployment line returned including a 19 cm single fiber on the end.Additionally, 125 from the deployment knob, there is approximately 21 cm section of deployment line that is only a single fiber.The reminder 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.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9540964
• Report Number: 2017233-2020-00004
• Device Sequence Number: 2275467
• Product Code: PFV
• UDI-Device Identifier: 00733132623747
• UDI-Public: 00733132623747
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/27/2020

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: 10/03/2020
• Device Model Number: VBJR061502A
• Device Catalogue Number: VBJR061502A
• Device Lot Number: 17651003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• 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
• Patient Age: 77 YR