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 Material Fragmentation (1261)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.Complete section 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.

Event Description

The following was reported to gore: on (b)(6) 2021, a patient was implanted with a 13mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface(viabahn device) to treat central vein stenosis.The physician deployed the viabahn device.During the deployment, the deployment line broke into filaments in sheath.After checking the images, it was found the distal stent was expanded and the proximal end didn't expand (half of the stent didn't expand).The physician waited for about one minute and found the proximal end expanded on the images, then performed post dilation.The procedure was completed and the patient tolerated the procedure.The position of stent was slightly away with ideal position.The second endovascular procedure will be planned if necessary.

Manufacturer Narrative

Imaging evaluation summary: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.Five images (jpegs) submitted for evaluation, only 2 of the images are x-rays, shown below.The image(s) received cannot be used to perform an imaging evaluation due to the insufficient data and/or poor quality of the image(s) provided.Images provided do not allow for evaluation in relationship to this event.Engineering evaluation: the manufacturing records were reviewed, and the device lot met all pre-release specifications.Evaluation of the returned product confirms the deployment line is broken.The deployment knob was also found broken, but the cause of the broken deployment knob could not be established.The delivery catheter was returned without the endoprosthesis.The deployment knob is broken.The deployment line is still attached to the deployment knob.The deployment line is broken 46 cm from the knob.An additional 133cm of deployment line was returned.There are several individual deployment line fibers extending at the break location.The zipper is fully deployed.Dual lumen: appears unremarkable.Distal shaft: appears unremarkable.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12757709
• MDR Text Key: 281520627
• Report Number: 2017233-2021-02516
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Catalogue Number: VBH131002W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SJM FAST CATH SHEATH 12 FR. 12CM
• Patient Age: 66 YR
• Patient Sex: Male