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

Model Number	VBJR061002A
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/13/2019
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 reported that during an up and over case, the device was positioned over a.014 wire and deployment initiated.However, there was no tension on the deployment line and the deployment line was pulled completely out without device expansion.The device was removed from the patient.
Additional Manufacturer Narrative
Corrected data: h1.Type of reportable event.Additional manufacturer narrative: evaluation of the actual device revealed that this event does not meet the definition of a reportable malfunction event, therefore is retracted.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.A supplemental mdr is being submitted indicating that the initial medwatch report is inaccurate and unwarranted based on the investigation findings.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9570886
• Report Number: 2017233-2020-00016
• Device Sequence Number: 16238755
• Product Code: PFV
• UDI-Device Identifier: 00733132623969
• UDI-Public: 00733132623969
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/17/2020

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: 01/15/2022
• Device Model Number: VBJR061002A
• Device Catalogue Number: VBJR061002A
• Device Lot Number: 20225117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• 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: 01/09/2020
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1