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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 26928
Device Problems Entrapment of Device (1212); Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Event Description
It was reported that the stent inadvertently deployed.A 6x100x130 innova self-expanding stent was selected for use.While loading the stent delivery system onto the guidewire, the stent inadvertently deployed.The stent appeared to be stuck on the guidewire.The stent was removed from the guidewire.A new innova stent was used to complete the procedure.There were no patient complications.
 
Manufacturer Narrative
Device evaluated by mfr: upon receipt at our post market quality assurance laboratory, this innova self-expanding stent system was examined for damage.Visual examination revealed a kink to the outer sheath at 3.2cm from the nosecone.The stent was partially deployed and deformed.The section of the stent that is outside of the sheath measures approximately 1.5cm long.The tip of the device was rolled back onto itself.Microscopic examination revealed no additional damages.The pull rack and yellow thumbwheel lock was still in the manufactured position.A test guidewire was inserted into the device and was able to pass through with resistance, at the kinked sections.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed the stent is partially outside of the sheath.The froze on wire could not be confirmed; however, there is damage that could have contributed to it.
 
Event Description
It was reported that the stent inadvertently deployed.A 6x100x130 innova self-expanding stent was selected for use.While loading the stent delivery system onto the guidewire, the stent inadvertently deployed.The stent appeared to be stuck on the guidewire.The stent was removed from the guidewire.A new innova stent was used to complete the procedure.There were no patient complications.
 
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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
MDR Report Key11747977
MDR Text Key248049961
Report Number2134265-2021-05428
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08714729874027
UDI-Public08714729874027
Combination Product (y/n)N
PMA/PMN Number
P140028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/24/2021
Device Model Number26928
Device Catalogue Number26928
Device Lot Number0022842034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Date Manufacturer Received06/10/2021
Patient Sequence Number1
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