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

Model Number	VBJR061502A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The review of the manufacturing paperwork verified that the lot met all pre-release specifications.As the devices were not returned, no evaluation of the devices could be performed.
Event or Problem Description
On (b)(6) 2019, the patient was being treated for an unknown etiology using gore® viabahn® endoprostheses.It was reported the deployment line broke near the proximal end of the stent.The stent was reportedly approximately 75 percent deployed when the deployment line broke.It is reportedly unknown what caused the deployment to break.The deployment line that remained was reportedly too far down for the physician to grab to complete the deployment.The physician reportedly cut the hub of the catheter.The 6fr cook ansel sheath was exchanged for a 8fr cook ansel sheath.An attempt to retrieve the entire device by withdrawing it through the sheath was unsuccessful as the device would not come back into the sheath.It was reported the physician decided to surgically remove the device.A bypass procedure was also performed.The patient tolerated the procedure.
Additional Manufacturer Narrative
Corrected d6: the device was not implanted.A date was entered in error for the implant date.Corrected d7: the device was not explanted.A date was entered in error for the explant date.
Additional Manufacturer Narrative
Engineering evaluation states: there is no device or images available for evaluation.No root cause was found following an engineering evaluation.No anomalies or non-routine maintenance were identified that could be attributed to the failure seen in this event.Therefore, based off of the evaluation performed, no manufacturing cause could be identified.Engineering evaluation conclusion is inconclusive as it relates to the event description.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9504103
• Report Number: 2017233-2019-01264
• Device Sequence Number: 13972975
• Product Code: PFV
• UDI-Device Identifier: 00733132623747
• UDI-Public: 00733132623747
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: VBJR061502A
• Device Catalogue Number: VBJR061502A
• Device Lot Number: 20979360
• 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: 12/20/2019
• Supplement Report FDA Received Date: 01/13/2020; 02/07/2020
• 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: Hospitalization; Required Intervention