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

Model Number VBHR101002A

Device Problems Separation Failure (2547); Activation Failure (3270)

Patient Problem Pain (1994)

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.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 Description

The following information was report to gore: on june 8, 2022, a gore® viabahn® endoprosthesis (vsx device) was intended for use in the left subclavian artery (periscope sandwich technique) during treatment of a type b aortic dissection.After a cook tx2 device was implanted in the descending aorta.A vsx device was advanced to the treatment site over a 0.035" rosen wire through 8 fr destination sheath into12fr dry seal sheath.However, after deployment was initiated, the vsx device started to "bowstring" and stopped deploying.After multiple attempts to continue deployment, the physician attempted to remove the vsx device, delivery catheter and sheath in tandem.After multiple attempts to remove the vsx device, and deployment system, it could not be retrieved.The decision was made to cut the delivery catheter and deployment line at skin level and leave it in the aorta.The patient tolerated the procedure.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.Neither the cause for nor the occurrence of the primary reported device failure mode, deployment difficulty, could be independently confirmed with the available information.The reported information indicates the vsx device was used with another, non-gore, stent, and the vsx device ifu provide warning against use with other devices implanted fewer than 30 days as other devices may interfere with vsx device deployment.The reported difficulty withdrawing the device could also not be independently confirmed.Use of the vsx device with the other, newly implanted, cook tx2 device, may be related to both the reported deployment and withdrawal difficulty, but the cause for these reported device failure modes could not be established.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: 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: 14703951
• MDR Text Key: 294140604
• Report Number: 2017233-2022-03016
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132646043
• UDI-Public: 00733132646043
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VBHR101002A
• Device Catalogue Number: VBHR101002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male