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	VBHR091002A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information was reported to gore: on (b)(6) 2021, the patient underwent a revision of a previously implanted av access graft in the leg using a gore® viabahn® endoprosthesis with heparin bioactive surface.The device was advanced and to its intended location and implanted with no issue.However, once the device was withdrawn it was noted the tip of the catheter had separated in the patients leg.Another gore device was used to pin the tip of the catheter to the previous implanted grafts.The patient tolerated the procedure.
Additional Manufacturer Narrative
A3 gender - female.D6a implant date - (b)(6) 2022.Engineering evaluation: the cause of the reported primary device failure mode, distal tip separation during removal, could not be confirmed.No items were returned for evaluation.The manufacturing records were reviewed.The device lot met all pre-release specifications.B4 description of event - correction to implant date.
Event or Problem Description
On (b)(6) 2021, the patient underwent a revision of a previously implanted av access graft in the leg using a gore® viabahn® endoprosthesis with heparin bioactive surface.The device was advanced and to its intended location and implanted with no issue.However, once the device was withdrawn it was noted the tip of the catheter had separated in the patients leg.Another gore device was used to pin the tip of the catheter to the previous implanted grafts.The patient tolerated the procedure.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12550986
• Report Number: 2017233-2021-02415
• Device Sequence Number: 3907786
• Product Code: PFV
• UDI-Device Identifier: 00733132645985
• UDI-Public: 00733132645985
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2022

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: 01/19/2023
• Device Model Number: VBHR091002A
• Device Catalogue Number: VBHR091002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 09/29/2021; 06/13/2022
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 06/01/2022; 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female