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

Catalog Number	VBJR061002A
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	09/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of unknown type and anatomical location with a gore® viabahn® endoprosthesis.When deployment was attempted, the proximal end of the stent would not expand.The delivery catheter was then pulled back and the stent came back with it.The delivery catheter then separated from the stent and then the stent deployed.A second stent was needed to bridge to the first one, and the procedure was concluded.
Additional Manufacturer Narrative
Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
Additional Manufacturer Narrative
H.6.Results code 2: 213: the engineering evaluation stated the following: the following observations were made: the endoprosthesis was not returned.There was approximately 178 cm of deployment line returned attached to the deployment knob.The deployment line, deployment knob, and delivery catheter were unremarkable.Engineering evaluation conclusion is inconclusive as it relates to the event description.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: 7947558
• Report Number: 2017233-2018-00601
• Device Sequence Number: 931207
• Product Code: PFV
• UDI-Device Identifier: 00733132623969
• UDI-Public: 00733132623969
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/28/2018

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: 04/16/2021
• Device Catalogue Number: VBJR061002A
• Device Lot Number: 18166089
• Was Device Available for Evaluation?: No
• 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: 10/09/2018
• Supplement Report FDA Received Date: 11/04/2018; 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1