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

Model Number	VBJR052502A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
The following was reported to gore: on (b)(6) 2021, a gore® viabahn® endoprosthesis was to be implanted in the superficial femoral artery to treat occlusion.After the device was advanced up and over the aortic bifurcation to the treatment sight, the physician started to deploy the device when the deployment line broke.Under fluoroscopy it was noticed that approximately half of the device was deployed.The physician advanced the introducer sheath to the device and tried remove the device and sheath in tandem.During the attempted removal, the device had become dislodged in the common femoral artery.On an unknown date, the patient had a surgical conversion performed to explant the device.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The device was discarded at the facility.Consequently, a direct product analysis was not possible.H6 - health effect - impact code, added code 4625 (additional surgery).H6 - investigation findings.Changed to code 213 (no device problem found).H6 - investigation conclusions, changed to code 4315 (cause not established).

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11158291
• Report Number: 2017233-2021-01595
• Device Sequence Number: 11664510
• Product Code: NIP
• UDI-Device Identifier: 00733132623938
• UDI-Public: 00733132623938
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: VBJR052502A
• Device Catalogue Number: VBJR052502A
• 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: 01/08/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 78 YR
• Patient Sex: Male