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

Model Number	VBJR050702A
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Malposition of Device (2616); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
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.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Results of device evaluation are pending completion of investigation and will be provided in final report.
Event or Problem Description
It was reported to gore that during a in stent restenosis (isr) procedure the gore® viabahn® endoprosthesis with heparin bioactive surface was unable to be deployed due to deployment line break.Reportedly the physician was unable to pull the device back into the sheath nor were they able to remove the device from the patient.It was reported that the patient was transferred to a local hospital to remove the device.Reportedly patient status is unknown at this time nor the outcome of the procedure.Per the fsa, patient was transported to local hospital ((b)(6) hospital center).Upon which the surgeon observed that the undeployed gore® viabahn® endoprosthesis with heparin bioactive surface stent was caught on the original stent strut (manufacturer unknown), this was why the stent was unable to be removed when deployment failed.Reportedly once vsx was pulled free, the vsx deployed and was removed successfully.It was reported that the procedure was completed with another gore vsx device and the patient tolerated the procedure.
Additional Manufacturer Narrative
The reported device failure mode, deployment line breaks, was confirmed during physical examination of the returned device.The cause of the device failure mode could not be determined.The complaint reports the vsx device was caught on the existing stent during attempted removal.It is not known how long the existing stent had been implanted, and a relationship between the broken deployment line and the existing stent could not be established.
Event or Problem Description
It was reported to gore that during a in stent restenosis (isr) procedure the gore® viabahn® endoprosthesis with heparin bioactive surface was unable to be deployed due to deployment line break.Reportedly the physician was unable to pull the device back into the sheath nor were they able to remove the device from the patient.It was reported that the patient was transferred to a local hospital to remove the device.Reportedly patient status is unknown at this time nor the outcome of the procedure.Per the fsa, patient was transported to local hospital (b)(6) hospital).Upon which the surgeon observed that the undeployed gore® viabahn® endoprosthesis with heparin bioactive surface stent was caught on the original stent strut (manufacturer unknown), this was why the stent was unable to be removed when deployment failed.Reportedly, once vsx was pulled free, the device deployed.However, it unintentionally covered the profunda.It was reported that the procedure was completed with another gore vsx device to treat the originally intended lesion.At a later date, the physician performed a follow-up procedure and uncovered the profunda successfully.The patient tolerated all interventional procedures.
Additional Manufacturer Narrative
Revised the description of event with the additional information received from the field.
Event or Problem Description
It was reported to gore that during a in stent restenosis (isr) procedure the gore® viabahn® endoprosthesis with heparin bioactive surface was unable to be deployed due to deployment line break.Reportedly the physician was unable to pull the device back into the sheath nor were they able to remove the device from the patient.It was reported that the patient was transferred to a local hospital to remove the device.Reportedly patient status is unknown at this time nor the outcome of the procedure.Per the fsa, patient was transported to local hospital (washington hospital center).Upon which the surgeon observed that the undeployed gore® viabahn® endoprosthesis with heparin bioactive surface stent was caught on the original stent strut (manufacturer unknown), this was why the stent was unable to be removed when deployment failed.Reportedly once vsx was pulled free, the vsx deployed successfully covering the profunda.It was reported that the procedure was completed with another gore vsx device and the patient tolerated the procedure.
Additional Manufacturer Narrative
This report is being sent to include the additional information received from the field.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14196894
• Report Number: 2017233-2022-02881
• Device Sequence Number: 19935435
• Product Code: NIP
• UDI-Device Identifier: 00733132624089
• UDI-Public: 00733132624089
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: VBJR050702A
• Device Catalogue Number: VBJR050702A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 03/28/2022; 03/28/2022; 03/28/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/26/2022; 08/03/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown