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

Catalog Number PAH131002E

Device Problems Separation Failure (2547); Difficult or Delayed Activation (2577)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.As the device remains implanted, no investigation on the device can be performed.However the delivery system was returned for further investigation and images were provided to perform an imaging evaluation.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

It was reported to gore that patient underwent endovascular treatment for an occlusion in the internal iliac artery (iia) with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated that during deployment of the viabahn-device, the final 2 cm got a little bit stuck, like resistant to open.However, when the deployment line was released a bit the distal part opened up without pulling the pull knob anymore.It was reported that it was impossible to retrieve the deployment line, although the stent seemed to be fully deployed.The deployment line was cut from the distal end of the catheter, to get the catheter out and to give the deployment line a pull closer to the introducer sheath, but the stent seemed to come downwards with the pulls.It was stated that the next step was trying to get the deployment line into a guiding catheter, push the catheter towards the distal end of the stent, to see if the deployment line would release itself, but this also did not work.It was reported that then a snare wire over the deployment line of the viabahn-device (also over the guiding catheter) was used to grab the deployment line as close to the stent as possible.A firm pull was performed on the snare and on the tread of the viabahn-device, then the deployment line was released / broken.It was stated that it is not known how much of the deployment line is still behind the stent / inside the patient.The viabahn-device was then post-dilated with a 12mm balloon.The completion angiogram showed a good result.

Manufacturer Narrative

Imaging evaluation summary: angiography images dated (b)(6) 2021 were provided to gore for evaluation.The evaluation showed the following: series 6 there appears to be a guidewire within the implanted/deployed graft.Final 2 angiograms show a deployed and patent graft, deployment line not visualized.No foreign body is visualized within the graft on final angiograms.Engineering evaluation summary: the device catheter was provided to gore for evaluation.The evaluation showed the following: the causes of the reported stuck deployment line and missing deployment knob could not be confirmed.The complaint reports the deployment line was cut, so evaluation does not conclude the deployment line broke.The delivery catheter was returned without the endoprosthesis and deployment knob, and the deployment line was found in a separate bag.There is fraying and a single fiber on one end of the deployment line.The delivery catheter appears unremarkable.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12171509
• MDR Text Key: 261686265
• Report Number: 2017233-2021-02170
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Catalogue Number: PAH131002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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 Age: 50 YR
• Patient Sex: Male