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

Model Number	VBJR051002A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
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: the patient presented with an unknown etiology at an unknown anatomical location and underwent treatment utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx).The physician was attempting to deploy the vsx device and the deployment line reportedly broke resulting in the catheter being caught on a strut.Further information has been requested but is not made available at this time.
Additional Manufacturer Narrative
Manufacturing records were reviewed and the device met all pre-release specifications.The device and delivery system were returned to gore for evaluation.The deployment line was returned in two segments, and the returned segment attached to the deployment knob was longer (147cm) than the nominal length of the catheter (120cm).This indicates the deployment line likely broke in the zipper section along the endoprosthesis.Cause of the reported event cannot be established based on evaluation of the returned device 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.
Event or Problem Description
The following was reported to gore: on (b)(6) 2021 a physician was attempting to reline a previously implanted stenosed bare metal stent in the superficial femoral artery (sfa) of a patient utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx) device.While attempting to reline the bare metal stent (bms) with the vsx device, the vsx device became caught on a strut of the bms, causing the deployment line to break.The device and delivery system were removed from the patient.The patient tolerated the procedure with no adverse outcomes.
Additional Manufacturer Narrative
H6: investigation conclusion code changed from 4315 to 4311.

• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11805915
• Report Number: 2017233-2021-01968
• Device Sequence Number: 3659214
• Product Code: NIP
• UDI-Device Identifier: 00733132623914
• UDI-Public: 00733132623914
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2022

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: 09/18/2022
• Device Model Number: VBJR051002A
• Device Catalogue Number: VBJR051002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 01/05/2022; 03/17/2022
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 02/24/2022; 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown