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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 26924
Device Problems Entrapment of Device (1212); Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2024
Event Type  malfunction  
Event Description
It was reported that device entrapment and premature deployment occurred.The patient underwent percutaneous transluminal angioplasty and stenting of the 90% stenosed target lesion located in the severely tortuous and severely calcified superficial femoral artery via contralateral approach.A 6f 45cm catapult guide sheath was advanced with difficulty over the iliac bifurcation followed by crossing a 035 non-boston scientific (bsc) guidewire into the lesion.Pre-dilatation was performed with a 5 x 220 sterling balloon catheter with 60% residual stenosis.A 6 x 60 x 130 innova vascular stent was advanced for treatment.It was noted that the guidewire was flushed with heparinized saline.However, during insertion, the stent got stuck on the guidewire and started to deploy outside the patient before ever getting into the sheath.The stent and the guidewire had to be removed together due to the wire being stuck in the sheath.The procedure was completed with a stiff zipwire and a 6 x 80 innova vascular stent.No patient complications were reported.
 
Manufacturer Narrative
The device was returned for evaluation.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent is partially deployed 28mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The pull rack and yellow thumbwheel lock is still in the manufactured position.Device to device interaction test was performed and the device was able to track over a test guidewire with some resistance at the kinked location.Inspection of the remainder of the device, revealed no other damage or irregularities.No other issues were identified during the product analysis.
 
Event Description
It was reported that device entrapment and premature deployment occurred.The patient underwent percutaneous transluminal angioplasty and stenting of the 90% stenosed target lesion located in the severely tortuous and severely calcified superficial femoral artery via contralateral approach.A 6f 45cm catapult guide sheath was advanced with difficulty over the iliac bifurcation followed by crossing a 035 non-boston scientific (bsc) guidewire into the lesion.Pre-dilatation was performed with a 5 x 220 sterling balloon catheter with 60% residual stenosis.A 6 x 60 x 130 innova vascular stent was advanced for treatment.It was noted that the guidewire was flushed with heparinized saline.However, during insertion, the stent got stuck on the guidewire and started to deploy outside the patient before ever getting into the sheath.The stent and the guidewire had to be removed together due to the wire being stuck in the sheath.The procedure was completed with a stiff zipwire and a 6 x 80 innova vascular stent.No patient complications were reported.
 
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Brand Name
INNOVA VASCULAR
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18743853
MDR Text Key335843644
Report Number2124215-2024-07429
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08714729874003
UDI-Public08714729874003
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 Physician
Type of Report Initial,Followup
Report Date 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26924
Device Catalogue Number26924
Device Lot Number0028428256
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE: .035 COOK ROAD RUNNER; GUIDEWIRE: .035 COOK ROAD RUNNER
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