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

Catalog Number	VBC080502
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing records verified that this lot met all pre-release specifications.
Event or Problem Description
It was reported to gore that a 8mm x 5cm gore® viabahn® endoprosthesis was to be implanted for treatment of the right common iliac artery aneurysm.When the device was advanced to the target lesion, the physician initiated the deployment line.When the device was deployed around 1-2cm, the deployment line got stuck and could not be deployed further.Then the physician retracted the device out of the patient together with the delivery system and the physician used the bard fluency graft to complete the procedure.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
An engineering evaluation was performed on the returned device.The evaluation results stated that the entire device was returned.There was approximately 18 cm of deployment line between the hub and deployment knob.There was a kink in the distal shaft, upon which the endoprosthesis is mounted, at the transition.The distal shaft was exposed approximately 0.5 cm at the transition.The endoprosthesis was longitudinally compressed towards the tip end of the device.The endoprosthesis was partially expanded approximately 1.5 cm at the tip end of the endoprosthesis.The remainder of endoprosthesis was still constrained.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.The remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9407171
• Report Number: 2017233-2019-01207
• Device Sequence Number: 3232160
• Product Code: PFV
• UDI-Device Identifier: 00733132614585
• UDI-Public: 00733132614585
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/16/2019

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: 11/26/2021
• Device Catalogue Number: VBC080502
• Device Lot Number: 20621869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• 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: 12/03/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 60