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

Catalog Number	VBHR081002A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device is currently in progress.An engineering investigation is currently in progress.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of an av access vessel stenosis in the thigh with a gore® viabahn® endoprosthesis.No adverse outcomes were reported and the patient tolerated the procedure.On (b)(6) 2019 a balloon angioplasty was performed in a non-treated segment of the vessel.When the balloon catheter was being removed from the vessel, through the previously implanted viabahn, some resistance was noted.The balloon catheter and sheath were removed together.An olive tip with a small segment (approximately 10 mm) of a delivery catheter came out along with the balloon catheter and sheath.There was no adverse outcome for the patient.
Additional Manufacturer Narrative
Results code 2: 213: the engineering evaluation stated the following: the distal shaft, upon which the endoprosthesis was mounted, and the distal tip were returned.The distal shaft was kinked approximately 8 cm from the tip end of the distal shaft.The distal shaft measured approximately 13 cm from the tip end of the distal shaft and the pebax did not appear to be disrupted on the transition end of the distal shaft.Engineering evaluation conclusions are: transition bond separation.Based on the device examination performed, this event has the potential to relate to a manufacturing deficiency.Conclusion code 1: updated.
Additional Manufacturer Narrative
H.3.Updated.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8652148
• Report Number: 2017233-2019-00375
• Device Sequence Number: 10833990
• Product Code: PFV
• UDI-Device Identifier: 00733132623136
• UDI-Public: 00733132623136
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2019

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: 03/24/2021
• Device Catalogue Number: VBHR081002A
• Device Lot Number: 18070499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• 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: 05/29/2019
• Supplement Report FDA Received Date: 06/30/2019; 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR