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

Catalog Number VBJR051502A

Device Problems Difficult to Remove (1528); Component Missing (2306); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

A gore viabahn® endoprosthesis was used during the treatment of superficial femoral artery (sfa) total occlusion.The targeted site was predilated and the device was then advanced through a 6fr introducer sheath.The vessel was severely calcified.During advancement, the user had difficulty advancing the device across the lesion.After multiple attempts which required catheter manipulation, the device still would not cross the lesion.The user had difficulty removing the device back through the sheath.During the attempts to remove the device, the device spontaneously deployed in the external iliac artery.After the removal of the delivery catheter, the physician noticed the delivery catheter¿s distal tip was missing.A bare metal stent was deployed to pin the detached delivery catheter¿s distal tip against the vessel wall.Good flow was observed through the gore viabahn® endoprosthesis deployed in the external iliac artery.Another bare metal stent was deployed to treat the sfa total occlusion.The patient was fine post procedure.

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.A portion of the delivery catheter was returned and an engineering evaluation was performed.The following observations were made: the device was returned with the guidewire still in the catheter.The endoprosthesis, distal tip and a majority of the distal shaft was not returned with the rest of the device.Approximately 5 mm of the distal shaft remained protruding from the dual lumen at the transition.Approximately 82 cm of the deployment line was protruding from the transition.The end of the deployment line appeared normal.The dual lumen appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.The user attempted to remove the device back into the introducer sheath.Per instructions for use -warnings section states, "do not withdraw the gore viabahn® endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore viabahn® endoprosthesis back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore viabahn® endoprosthesis to a position close to but not into the introducer sheath.Both the gore viabahn® endoprosthesis and introducer sheath can then be removed in tandem.".

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4652892
• MDR Text Key: 20771758
• Report Number: 2017233-2015-00204
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• 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
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2017
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 13306128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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
• Patient Age: 75 YR
• Patient Weight: 82