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

Device Problems Material Separation (1562); Separation Problem (4043)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

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 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surface.The device was advanced and to its intended location and implanted with no issue.However, once the device was withdrawn it was noted the tip of the catheter had separated in the patients leg.Another gore device was used to pin the tip of the catheter to the previous implanted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.

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 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surface.The device was advanced and to its intended location and implanted with no issue.However, once the device was withdrawn it was noted the tip of the catheter had separated in the patients leg.Another gore device was used to pin the tip of the catheter to the previous implanted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
• Type of Device: 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
• MDR Text Key: 275007358
• Report Number: 2017233-2021-02415
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132645985
• UDI-Public: 00733132645985
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female