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

Model Number	VBH131002A
Medical Device Problem Codes	Separation Failure (2547); Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Fistula (1862); Pseudoaneurysm (2605)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore: the patient presented for av fistula pseudoaneurysm repair.The first gore® viabahn® endoprosthesis was placed without incident.The second gore® viabahn® endoprosthesis (oversized) was positioned and deployment started.As the deployment line was being pulled the device appeared to move so a gap was created between the two devices.To bridge the gap the doctor selected a third gore® viabahn® endoprosthesis.The third gore® viabahn® endoprosthesis was advanced into place and the deployment line pulled.The doctor placed his finger on the device as the resident slowly pulled the deployment line.After opening approximately 50%, the deployment line tension started to increase.After approximately 95% deployment, the deployment line stopped and appeared to be still attached to the device.The doctor removed the catheter and threaded the deployment line into another catheter, then pulled the deployment line while advancing the catheter, thus the device eventually partially opened.The doctor ballooned the partially opened device with no success so completed the procedure by placing a bare metal stent to hold the gore® viabahn® endoprosthesis open.The patient is fine.
Additional Manufacturer Narrative
Additional information: the device was not returned.Consequently, a direct product analysis was not possible.The following information was evaluated: dhr lot review for final devices and constraining sleeves using the master process sheets for rejects related to the aforementioned reported event; machine files for the loaders and constraining sleeve braiders near the time of manufacturing of the devices and constraining sleeves were evaluated for non-routine maintenance that could potentially contribute to deployment related issues.Based off of the evaluation performed, no manufacturing cause could be identified.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9589447
• Report Number: 2017233-2020-00032
• Device Sequence Number: 11681039
• Product Code: PFV
• UDI-Device Identifier: 00733132623297
• UDI-Public: 00733132623297
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 08/08/2022
• Device Model Number: VBH131002A
• Device Catalogue Number: VBH131002A
• Device Lot Number: 21133091
• 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
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 69