MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Model Number	VBJR080502A
Medical Device Problem Codes	Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Event or Problem Description
The following was reported to gore: on (b)(6) 2021 a patient presented with stenosis in an av fistula and underwent treatment utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx) device.The physician had difficulty advancing the guidewire, catheter, and balloon to the lesion due to the patients tortuous anatomy.The physician was ultimately able to advance the device to the lesion, but when he attempted to deploy the vsx device, the distal end of the device would not fully deploy.The physician completely removed the device and delivery system.The physician reported that he was able to fully deploy the device once it was outside of the patient, so he suspects the partial deployment was due to tortuous anatomy and calcification and not a defect with the device.The device will be returned.No other device was used to complete the procedure.The patient tolerated the procedure.
Additional Manufacturer Narrative
Manufacturing records were reviewed and the device met all pre-release specifications.The device was returned to gore without the delivery system.The endoprosthesis was returned fully expanded and was otherwise unremarkable.Cause of the reported event cannot be established based on evaluation of the returned device, however, information originally reported by the physician indicates this event is potentially related to the patients tortuous anatomy.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.Pma/510(k)number corrected to p130006.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12211815
• Report Number: 2017233-2021-02193
• Device Sequence Number: 19628260
• Product Code: PFV
• UDI-Device Identifier: 00733132623815
• UDI-Public: 00733132623815
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 01/17/2023
• Device Model Number: VBJR080502A
• Device Catalogue Number: VBJR080502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown