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

Catalog Number	VBJR061002A
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results code: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was being treated emergently for a hemorrhage.A gore® viabahn® endoprosthesis was loaded over a.018" wire and advanced, but during advancement, the delivery catheter broke.The device was removed entirely and a second device was advanced and deployed successfully.There was no adverse outcome for the patient.
Additional Manufacturer Narrative
Results code2: 213: the engineering evaluation stated the following: there was a kink in the distal shaft, upon which the endoprosthesis is mounted, at the transition.The remainder of the device appeared unremarkable.Medwatch #2017233-2018-00730 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch will be retracted.Engineering evaluation conclusions are: based on the device examination performed, no manufacturing anomalies were identified.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was being treated emergently for a hemorrhage.A gore® viabahn® endoprosthesis was loaded over a.018" wire and advanced, but during advancement, the delivery catheter broke.The device was removed entirely and a second device was advanced and deployed successfully.There was no adverse outcome for the patient.During the course of the investigation it was learned that the delivery catheter did not break apart, but rather it kinked.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8123024
• Report Number: 2017233-2018-00730
• Device Sequence Number: 1569387
• Product Code: PFV
• UDI-Device Identifier: 00733132623969
• UDI-Public: 00733132623969
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: 03/11/2021
• Device Catalogue Number: VBJR061002A
• Device Lot Number: 18269834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• 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: 12/01/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR