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

Catalog Number VBH131002W

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.Imaging evaluation: three non-dicom/jpeg images submitted for evaluation.Image appears to depict vessel irregularity.Second image appears to demonstrate the use of a pta balloon.Third blurry image appears to demonstrate a deployed device.The image(s) received cannot be used to perform a full imaging evaluation due to insufficient data in relation to the reported event and/or poor quality of the image(s) provided.The device remains implanted and delivery catheter was discarded by hospital facility.Therefore, no engineering evaluation could be performed.Cause of the reported event cannot be established based on evaluation of the images and the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on (b)(6) 2022, a patient was to be implanted with a 13mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to treat brachiocephalic vein occlusion.The right brachiocephalic vein of the patient was stenosis.A cook 12 fr sheath was used to puncture from right cephalic vein, and a 55 cm sheath was used.A terumo 0.035¿¿ guidewire was inserted through right brachiocephalic vein to inferior vena cava.A 12mm x 80mm balloon was used to pre-dilate the target lesion and viabahn device was advanced to the target lesion.Physician initiated the deployment and viabahn device completed the fully expansion.But physician found that the deployment line couldn't be removed afterwards.Per dsa imaging, physician suspected that the deployment line stuck on the viabahn device near the middle portion of the device.In order to remove deployment line, physician tried to advance delivery catheter or to use a 12mm x 40mm balloon to dilate the viabahn, deployment line cannot be removed.Therefore, physician cut the deployment line and remove it.A deployment line fragment was stuck with the device and left in patient.Imaging showed the right brachiocephalic vein was patent.Patient tolerated the procedure.

Manufacturer Narrative

E1: update country from japan to china.

• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13925461
• MDR Text Key: 289080010
• Report Number: 2017233-2022-02826
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2024
• Device Catalogue Number: VBH131002W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 72 KG