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

Catalog Number	VBJR082502A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A4: patient weight was requested but not made available.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code c21: conclusion not yet available.Evaluation is currently in progress.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following was reported to gore: during treatment of a stenosis in the patient's superficial femoral artery, access was made from the contralateral side.As reported, there were existing devices at the aortic bifurcation, but not at the intended treatment area.An 8fr destination sheath was used to advance a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) over an 0.018 grand slam wire.The viabahn device reached the intended treatment area and deployment was initiated.The deployment line became stuck after about a third of the viabahn device expanded.The deployment line could not be released any further.Consequently, a 12fr x 80cm cook sheath was inserted from the contralateral side, and the sheath was used to cover the partially expanded device.The viabahn device and sheath were then removed together.The procedure continued with deployment of two additional viabahn devices.As reported, the procedure time was prolonged due to the extra measures taken to remove the partially expanded viabahn device.The procedure ended with good results and the patient tolerated the procedure.It was reported the physician did not have an opinion of why the deployment line became stuck.
Additional Manufacturer Narrative
D9 was updated as device was returned for evaluation.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code c20: engineering evaluation: the reported failure mode of partial deployment or deployment line stuck is consistent with the findings of broken deployment line, and signs of stress on the catheter including bunching, columnar failure, and necking.Engineering evaluation of the device could not confirm the reported failure of partial deployment because the observable portion of the endoprosthesis appeared to be deployed, and the endoprosthesis could not be removed from the sheath for further analysis.Replication of this failure mode is not always possible because of differences between conditions seen in vivo (i.E., patient anatomy, procedural conditions) and those seen in the laboratory.The root cause of the reported failure mode could not be established with the available information.

• 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: 19757487
• Report Number: 2017233-2024-05114
• Device Sequence Number: 8850715
• Product Code: NIP
• UDI-Device Identifier: 00733132623693
• UDI-Public: 00733132623693
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 03/12/2026
• Device Catalogue Number: VBJR082502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male