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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26920
Device Problem Premature Activation (1484)
Patient Problem No Patient Involvement (2645)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the stent deployed prematurely.An 8x80x130 innova stent was selected for use for a patient procedure.When the surgeon removed the device from the packaging, it was noted that the stent was already deployed.Therefore the device was not used.The procedure was completed successfully after replacing the device with a new innova stent.No patient complications were reported.The patient was not affected by the reported issue.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the stent deployed prematurely.An 8x80x130 innova stent was selected for use for a patient procedure.When the surgeon removed the device from the packaging, it was noted that the stent was already deployed.Therefore the device was not used.The procedure was completed successfully after replacing the device with a new innova stent.No patient complications were reported.The patient was not affected by the reported issue.Device evaluated by mfr: the returned product consisted of an innova self-expanding stent delivery system (sds).The outer sheath, mid-shaft, and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.It was noticed that the stent was partially deployed approximately 7mm from the distal side of the markerband.The thumbwheel was rotated to verify functionality of the device.The stent started to deploy as designed with no issues.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
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Brand Name
INNOVA
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7799724
MDR Text Key117697997
Report Number2134265-2018-60054
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/03/2020
Device Model Number26920
Device Catalogue Number26920
Device Lot Number0021463667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2018
Date Manufacturer Received10/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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