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

Catalog Number VBH060502

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Injury (2348); Vascular Dissection (3160)

Event Date 08/13/2014

Event Type  Injury  

Event Description

Patient was in cardiac catheterization lab for a peripheral procedure.A stent was successfully deployed to the right superficial femoral artery without incident.Stent #2 was deployed in the left common iliac.Upon removal of delivery device, excess pressure was noted.Doctor was notified that it did not feel right at which time they attempted to pull delivery device from the left femoral artery.Doctor successfully removed the delivery device.However, during the removal of the delivery device, a sheath was also pulled out at which time it was noted that approximately 20mm of stent was outside of the body.The doctor then attempted to remove stent completely from the patient's body by pulling on it.That caused the stent to shear in half.Manual pressure was held.Consult was done by another physician.Ultimately, the decision was made to take this patient to surgery in order to remove the remaining stent and repair their artery.Once in the or the doctor performed an emergent repair of right common femoral artery injury/dissection.

• Brand Name: VIABAHN
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth st.; flagstaff AZ 86004
• MDR Report Key: 4097808
• MDR Text Key: 4703019
• Report Number: 4097808
• Device Sequence Number: 1
• Product Code: NIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: VBH060502
• Device Lot Number: 10812230
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR