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

Catalog Number	VBJR051502A
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a superficial femoral artery in-stent stenosis.The intent was to reline the stent with a gore® viabahn® endoprosthesis.When the device was advanced to the target location, deployment was attempted, but after the device was deployed half way, the deployment line broke.The delivery catheter was then cut to try to expose the remaining deployment line.The delivery catheter was peeled open and the deployment line was exposed.The deployment line was pulled, and deployment was completed.Upon removal of the delivery system it was noted the deployment line was knotted.A second device was deployed to complete the treatment and the patient outcome was good.
Additional Manufacturer Narrative
H.6.Results code 2: 213: the engineering evaluation stated the following: part of the deployment line attached to the deployment knob, and two sections of the delivery catheters were returned.The deployment line appeared to be broken.It measured 149cm with a 7.5cm single fiber coming from the end.There were two knots in the deployment line approximately 50.5cm and 55cm from the deployment knob.The delivery catheter appeared to be cut and resulted in 2 pieces.The pieces measured 32cm and 93cm.Approximately 39cm of the section of delivery catheter that included the distal tip was cut down the middle.Engineering evaluation conclusion(s) are: deployment line broken.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8880306
• Report Number: 2017233-2019-00607
• Device Sequence Number: 10819751
• Product Code: PFV
• UDI-Device Identifier: 00733132623921
• UDI-Public: 00733132623921
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/22/2019

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: 08/02/2020
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 17459604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• 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: 08/09/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1