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

Catalog Number VBH111002

Device Problems Failure to Advance (2524); Material Distortion (2977)

Patient Problem Blood Loss (2597)

Event Date 12/13/2013

Event Type  Injury  

Event Description

Patient presented with a right popliteal aneurysm.A 12fr gore dryseal sheath was used to advance the gore viabahn endoprosthesis over a.035 bentson guidewire.The gore viabahn endoprosthesis did not advance to the target site and was removed from the patient.The distal end of the withdrawn gore viabahn endoprosthesis had become distorted.The target sit was re-ballooned using 9mm x 4 cm conquest balloon.The same gore viabahn endoprosthesis was advanced because the physician wanted to see if the same device would reach the target site.The gore viabahn endoprosthesis did not reach target site and was being withdrawn when the device got hung up on distal end of 12fr gore dryseal sheath.The sheath was removed while the gore viabahn endoprosthesis remained in the patient.A femoral artery cut down was performed in order to remove the gore viabahn endoprosthesis.Another 12fr gore sheath was placed and a new gore viabahn endoprosthesis was opened.However, decision was made to abort the treatment due to blood loss and inability to advance gore viabahn endoprosthesis to target site.Patient was stable at end of the procedure.

Manufacturer Narrative

Review of the device manufacturing record history confirmed device met pre-release specifications.Engineering evaluation state the gore viabahn endoprosthesis is compressed distally approximately 5.5cm.Some expansion was noted at the proximal end of the endoprosthesis.The deployment line is severed and approximately 1.5cm of the compressed outer layer of zipper is deployed.There is also a kink in the dual lumen approximately 38cm from the hub.Based on the examination performed, no anomalies were found that could be attributed to the mfr of the device.The warnings section of the ifu state: do not withdraw the gore viabahn endoprosthesis with heparin bioactive surface back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore viabahn endoprosthesis with heparin bioactive surface 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 with heparin bioactive surface to a position close to but not into the introducer sheath.Both the gore viabahn endoprosthesis with heparin bioactive surface and introducer sheath can then be removed in tandem.After removal, do not use the gore viabahn endoprosthesis with heparin bioactive surface oar introducer sheath.

• Brand Name: GOR VIABAHN ENDOPROSTHESIS
• Type of Device: NIP / STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer Contact: genevieve begay ; 3250 w kiltie lane; flagstaff, AZ 86005 ; 9285263030
• MDR Report Key: 3581515
• MDR Text Key: 4059773
• Report Number: 2017233-2014-00008
• 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: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: VBH111002
• Device Lot Number: 11376118
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/27/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR