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

Model Number VBJR061502A

Device Problems Failure to Deliver (2338); Detachment of Device or Device Component (2907)

Patient Problems Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following was reported to gore: on (b)(6) 2021, a 6mm x 15cm gore® viabahn® endoprosthesis (vsx) device was intended for use in the superficial femoral artery for treatment of stenosis.After the device was advanced across the lesion the physician attempted to deploy the vsx device.However, after the deployment line was removed from the patient, the physician attempted to remove the delivery catheter and felt resistance.An angiograph showed approximately 10 centimeters of the vsx device had full expansion and the remaining device was still constrained.The physician attempted to capture the device in the introducer sheath but was unsuccessful.The physician decided to pull the delivery catheter and vsx device to the access site, and perform a cut down to remove the vsx device.An additional vsx device was successfully delivered to complete the procedure.The patient did not experience any adverse consequences.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The endoprosthesis was returned.The cause of the device failure mode could not be determined.Cause of the reported event cannot be established based on evaluation of the returned delivery system and the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

Manufacturer Narrative

Revised b1 to capture adverse event and product problem - yes.Revised d2 product code.Revised g4 pma/510(k)number.Revised h6 health effect - clinical code.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12847775
• MDR Text Key: 282917077
• Report Number: 2017233-2021-02552
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623747
• UDI-Public: 00733132623747
• Combination Product (y/n): Y
• 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,Followup,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2022
• Device Model Number: VBJR061502A
• Device Catalogue Number: VBJR061502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male