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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26926
Device Problems Fracture (1260); Premature Activation (1484); Failure to Advance (2524); Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/18/2021
Event Type  Injury  
Event Description
It was reported that upon removal the stent fractured and a portion was left un-retrieved in the patient.An 5mm x 150mm x 130cm innova vascular self-expanding stent was chosen for a superficial femoral artery (sfa) angioplasty and stent placement to treat peripheral artery disease.The target lesion contained very high grade stenosis (possibly occluded) and was severely calcified.During the treatment, the innova stent catheter would not cross the lesion on first attempt.The physician removed the stent and exchanged the wire, and then the lesion was pre-dilated with a 4mm balloon before attempting to cross the lesion again.A second attempt to cross the lesion also failed, and upon removal the stent started to deploy and elongated across a portion of the diseased sfa before fracturing.Therefore, a portion of the stent remained in the patient un-retrieved and a portion came out with catheter.Further intervention was performed where three additional innova stents (5mm x 120mm, 5mm x 100mm, 6mm x 150mm) were deployed to cover the un-retrieved fractured portion of the stent and lesion.Subsequently, the sfa was opened with blood flow through all stent.The procedure was completed successfully using an alternative method without sequela.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed that the lock and rack were not in the manufactured location.The stent was outside of the sheath and stretched.The stent was separated 11.3 cm and the other section of the stent was missing.There was multiple buckling to the outer sheath 80.8cm to 83.1cm from the nosecone.There was a kink to the outer sheath at the nosecone.There was a kink to the inner liner 1.8cm from the tip.Microscopic examination revealed damage to the middle sheath 2mm from the distal end, and the tip was damaged.Inspection of the remainder of the device revealed no other damage or irregularities.Product found damage on the device that could have contributed to the reported event.
 
Event Description
It was reported that upon removal the stent fractured and a portion was left un-retrieved in the patient.An 5mm x 150mm x 130cm innova vascular self-expanding stent was chosen for a superficial femoral artery (sfa) angioplasty and stent placement to treat peripheral artery disease.The target lesion contained very high grade stenosis (possibly occluded) and was severely calcified.During the treatment, the innova stent catheter would not cross the lesion on first attempt.The physician removed the stent and exchanged the wire, and then the lesion was pre-dilated with a 4mm balloon before attempting to cross the lesion again.A second attempt to cross the lesion also failed, and upon removal the stent started to deploy and elongated across a portion of the diseased sfa before fracturing.Therefore, a portion of the stent remained in the patient un-retrieved and a portion came out with catheter.Further intervention was performed where three additional innova stents (5mm x 120mm, 5mm x 100mm, 6mm x 150mm) were deployed to cover the un-retrieved fractured portion of the stent and lesion.Subsequently, the sfa was opened with blood flow through all stent.The procedure was completed successfully using an alternative method without sequela.
 
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Brand Name
INNOVA VASCULAR
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12986645
MDR Text Key282196335
Report Number2134265-2021-15522
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08714729873952
UDI-Public08714729873952
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26926
Device Catalogue Number26926
Device Lot Number0027654474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
Patient SexFemale
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