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

Model Number VBH101502A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 04/22/2020

Event Type  Injury  

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 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advance over the lesion.The physician stated the suspected cause of the event is unknown.The device was attempted to be withdrawn back into the 11fr trumo sheath.However, the device could not be pulled back into the sheath.The device was then advanced back to the patients upper arm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
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marcos ayala ; 1500 n. 4th street; 9285263030
• MDR Report Key: 10043988
• MDR Text Key: 190652653
• Report Number: 2017233-2020-00352
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623235
• UDI-Public: 00733132623235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention