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

Catalog Number	VBC071002
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to gore that the patient had a stenosis of the left brachial artery, since the stenosis was not improved after pta treatment by a balloon, the physician used a gore® viabahn® endoprothesis for further treatment.The viabahn® device was advanced through a 8fr terumo sheath over a 26 cm 0.035 terumo stiff guide wire to the target lesion and initiated deployment.However, the deployment line was reportedly stuck in the second layer zipper and the device was expanded around 5 mm in the distal, the deployment could not continue.The device was retracted out of the patient through the sheath and a new viabahn® device was used to continue the procedure.
Additional Manufacturer Narrative
The device was returned and the engineering evaluation was performed.The following observations were made: the deployment knob was separate from the hub with 23 cm of deployment line between the knob and hub.Approximately 1 cm of the endoprosthesis was expanded on the tip end of the device.Approximately 3 cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed at the transition end of the device.There were 3 kinks in the distal shaft at 1.3, 1.8, and 2.9 cm from the transition.There are 2 flared struts in the first row of the endoprosthesis nearest to the transition.Deployment could be continued with traction on the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.
Additional Manufacturer Narrative
Result code 2 updated.Conclusion code 1 updated , conclusion code 2 added.Code 22 -per the gore® viabahn® endoprosthesis instructions for use (ifu), it is stated that complications and adverse events that can occur when using any endovascular device.These complications include but are not limited to deployment failure.
Additional Manufacturer Narrative
Concomitant medical products: updated.Method code 2 added.Results code 1 updated.Code 213 - the review of the manufacturing records verified that the lot met all pre-release specifications.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7841128
• Report Number: 2017233-2018-00533
• Device Sequence Number: 1980855
• Product Code: PFV
• UDI-Device Identifier: 00733132614530
• UDI-Public: 00733132614530
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup,Followup
• Report Date (Section B): 10/03/2018

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: No Information
• Device Expiration Date: 12/04/2020
• Device Catalogue Number: VBC071002
• Device Lot Number: 17745971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/28/2018; 10/10/2018; 10/16/2018
• 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: 85 YR
• Patient Weight: 53