MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	VBHR090502A
Medical Device Problem Codes	Break (1069); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient specific details have been provided, therefore the w.L.Gore internal case number is being used.(b)(4).The device itself remains implanted and the deployment system was discarded at the facility, therefore, direct product analysis was not possible.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) 2022, a patient presented with an unknown etiology and underwent treatment of a superficial femoral artery (sfa) utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx) device.The physician advanced the vsx device to the intended site using a 0.014" terumo glidewire advantage® guidewire.It was reported that the physician initiated deployment and when the device was approximately 2/3 of the way expanded, the deployment line broke.Ultimately, the physician was able to achieve full expansion and the vsx device was successfully implanted.All delivery system components were removed from the patient.The patient tolerated the procedure with no adverse impacts.The physician does not have any input as to what caused the deployment line to break.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 13693045
• Report Number: 2017233-2022-02790
• Device Sequence Number: 12085999
• Product Code: NIP
• UDI-Device Identifier: 00733132645947
• UDI-Public: 00733132645947
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: 07/24/2024
• Device Model Number: VBHR090502A
• Device Catalogue Number: VBHR090502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2021
• 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