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

Model Number	VBH101502A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The review of the manufacturing paperwork verified that this 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) 2020, the patient was being implanted with a gore® viabahn® endoprosthesis for av access in the upper arm.It was reported the device met resistance and was unable to advance over the lesion.The physician stated the suspected cause of the event is unknown.The device was attempted to be withdrawn back into the 11fr trumo sheath.However, the device could not be pulled back into the sheath.The device was then advanced back to the patients upper arm deployed and surgically removed.The procedure was completed with another device.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10043988
• Report Number: 2017233-2020-00352
• Device Sequence Number: 3468311
• Product Code: PFV
• UDI-Device Identifier: 00733132623235
• UDI-Public: 00733132623235
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 09/29/2022
• Device Model Number: VBH101502A
• Device Catalogue Number: VBH101502A
• Device Lot Number: 21405012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2020
• 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