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

Catalog Number	VBCR081001A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	01/10/2019
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 doctor, using percutaneous access during an av case, advanced the gore® viabahn® endoprosthesis through the wall of a vascular graft without a sheath.The device was advanced to the target area and deployed as expected.When the catheter was withdrawn from the patient it was observed that approximately 10cm of the distal end of the catheter was missing.Under fluoroscopy the doctor observed the end still on the wire inside the patient and was able to snag the broken piece from the patient.The gore® viabahn® endoprosthesis was reported by the doctor to be functioning as intended at the conclusion of the procedure.There was no injury to the patient.
Additional Manufacturer Narrative
Additional manufacturer narrative: examination of the returned device revealed the following: the deployment knob, deployment line and delivery catheter were returned; there was approximately 97 cm of deployment line between the deployment knob and hub; the dual lumen appeared broken where the transition bonds to the dual lumen about 67 cm away from the hub; the end of the dual lumen and transition where bonding normally occurs appeared to be malformed and curved; there appeared to be a lack of sufficient bonding between the dual lumen, transition, and distal shaft, upon which the endoprosthesis was mounted; the braid pattern of the distal shaft was visible inside of the dual lumen and transition, however, the pebax on the distal shaft did not appear to be melted; the transition was missing material inside of the transition which separates the guidewire and deployment line lumen; the transition was returned attached to the distal shaft, however, the transition was able to move on the distal shaft; there was a kink in the distal shaft 1.5 and 2 cm away from the proximal end of the distal shaft; there was approximately 12 cm of distal shaft attached to the distal tip.Based on the device examination performed, manufacturing anomalies were identified that potentially could have contributed to the event.All information has been placed on file for use in tracking and trending.Corrected data: conclusion code 1.
Additional Manufacturer Narrative
Additional manufacturer narrative: evaluation codes: results code 2.Conclusion code 1.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: 8290727
• Report Number: 2017233-2019-00053
• Device Sequence Number: 14062143
• Product Code: PFV
• UDI-Device Identifier: 00733132623525
• UDI-Public: 00733132623525
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 03/07/2019

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: 09/10/2021
• Device Catalogue Number: VBCR081001A
• Device Lot Number: 19993514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• 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: 01/30/2019
• Supplement Report FDA Received Date: 03/07/2019; 03/07/2019
• 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: 52 YR