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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); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: patient was over 18 years old.
 
Event Description
It was reported that the stent inadvertently deployed and the delivery system became froze on the wire and fractured.The target lesion was located in the right superficial femoral artery.Popliteal access was used with a 6fr super sheath.Two stents and balloons were used over the amplatz guidewire.An 8x80x130 innova self expanding stent was selected for use.During preparation for the procedure, the stent and delivery systems were appropriately flushed prior to loading and lock was in place.Upon insertion over the guidewire and during forward advancement outside the patient body, it was noted that the stent had partially deployed approximately 2cm.The physician attempted to remove the catheter but it had become stuck to the guidewire and could not be removed without using significant force which led to the inner shaft fracturing.The fragments were removed from the guidewire with extreme force.The procedure was completed successfully using another innova stent and different guidewire.No patient harm or complications were reported.
 
Manufacturer Narrative
A2: age at time of event: patient was over 18 years old.Device evaluated by manufacturer.Returned product consisted of an innova self-expanding stent system.The stent component was not returned.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed multiple kinks on the outer sheath, inner liner, and proximal inner.The proximal inner and inner liner is separated from the clip.Microscopic examination revealed no additional damages.The pull handle and yellow thumbwheel lock is still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent inadvertently deployed and the delivery system became froze on the wire and fractured.The target lesion was located in the right superficial femoral artery.Popliteal access was used with a 6fr super sheath.Two stents and balloons were used over the amplatz guidewire.An 8x80x130 innova self expanding stent was selected for use.During preparation for the procedure, the stent and delivery systems were appropriately flushed prior to loading and lock was in place.Upon insertion over the guidewire and during forward advancement outside the patient body, it was noted that the stent had partially deployed approximately 2cm.The physician attempted to remove the catheter but it had become stuck to the guidewire and could not be removed without using significant force which led to the inner shaft fracturing.The fragments were removed from the guidewire with extreme force.The procedure was completed successfully using another innova stent and different guidewire.No patient harm or complications were reported.
 
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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 Key10115260
MDR Text Key193691063
Report Number2134265-2020-07402
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08714729874195
UDI-Public08714729874195
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 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/30/2021
Device Model Number26924
Device Catalogue Number26924
Device Lot Number0022591651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Initial Date Manufacturer Received 05/12/2020
Initial Date FDA Received06/03/2020
Supplement Dates Manufacturer Received07/09/2020
Supplement Dates FDA Received07/29/2020
Patient Sequence Number1
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