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

Model Number	VBJR081502A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
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.Review of device manufacturing record history confirmed device met pre-release specifications.Specimen was returned; conclusion is not yet available as evaluation is currently in progress.
Event or Problem Description
The following was reported to gore: during a popliteal aneurysm endovascular procedure, a gore® viabahn® endoprosthesis with heparin bioactive surface (device) was advanced through a cook 7fr sheath over a.018 steelcore wire.The device was delivered to the target treatment and deployment was initiated.As device started to expand at the distal end, the patient suddenly moved, causing the device to lose purchase in the aneurysm.The slightly expanded device was able to be pulled back into the sheath and was removed from the patient with no issues.The procedure ended with no device placement.The patient did not experience any adverse consequences.As reported, physician stated there were no issues with the device.
Additional Manufacturer Narrative
This complaint is being retracted as there were no issues with device during deployment.During procedure, patient moved, causing loss of device purchase.The physician stated the device was not at fault.Patient was not harmed during this treatment.H6 - code 4311: during procedure, the device deployed as intended until the patient moved.Because of the patient¿s movement the device was no longer in the correct location so the physician decided to remove the device rather than attempt to continue deployment.It was determined this complaint was not reportable as device deployed as intended, was removed since deployment could not be continued.Patient did not experience any adverse consequences.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12362152
• Report Number: 2017233-2021-02304
• Device Sequence Number: 17105720
• Product Code: NIP
• UDI-Device Identifier: 00733132623839
• UDI-Public: 00733132623839
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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
• Report Date (Section B): 02/22/2022

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: 11/23/2022
• Device Model Number: VBJR081502A
• Device Catalogue Number: VBJR081502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2019
• 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: A
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 67 KG