MAUDE Adverse Event Report: EV3 ENDOVASCULAR, INC EV3 VISI-PRO; STENT

Model Number PXB35-08-27-135

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/28/2015

Event Type  Injury  

Event Description

During the scheduled stent placement, after having tried to place the stent and the stent not crossing the lesion, the stent was removed while still on the balloon.During the removal process the guide wire was also pulled out of the carotid artery.After removing everything a guiding catheter was placed over the guide wire to gain access to the carotid artery.After getting the guiding catheter outside of the sheath, we noticed a dark area on the guiding catheter.After checking the stent delivery system, it was determined that the stent was attached to the guiding catheter.The sheath and guiding catheter were slowly pulled back until the sheath was almost out of the patient.The stent then came off the guiding catheter after taking a picture of the iliac artery.The angled ss lt guide wire was attempted to be placed through the stent.Then a 150cm train blazer support catheter was attempted to be placed through the stent.After this failed attempt, an ensnare system was deployed to retrieve the stent.After this attempt failed, it was observed under fluro that the stent traveled down the right iliac artery to the profunda artery of the right lower limb.The stent that remained in the patient was an ev3 viso-pro 8mm by 27mm.

• Brand Name: EV3 VISI-PRO
• Type of Device: STENT
• Manufacturer (Section D): EV3 ENDOVASCULAR, INC; 3033 campus drive; plymouth MN 55441
• MDR Report Key: 4491682
• MDR Text Key: 5569130
• Report Number: MW5040607
• Device Sequence Number: 1
• Product Code: NIN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2016
• Device Model Number: PXB35-08-27-135
• Device Catalogue Number: PXB35-08-27-135
• Device Lot Number: 9832261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR