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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID
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BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26605
Device Problem Premature Activation (1484)
Patient Problem No Patient Involvement (2645)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that stent inadvertent deployment occurred.The target lesion was located in the internal carotid artery.A 8.0-21 carotid wallstent stent was selected for use.However, during preparation, it was noted that the stent deployed itself before the outer sheath was pulled back.The issue occurred outside the patient.There were no patient complications.The procedure was completed with another of the same device.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.A visual examination found that the stent of the device had been fully deployed.No damage or issues were noted with the deployed stent.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.Media was identified inside the device indicating that it was flushed in preparation for the procedure.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues along the length of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent inadvertent deployment occurred.The target lesion was located in the internal carotid artery.A 8.0-21 carotid wallstent stent was selected for use.However, during preparation, it was noted that the stent deployed itself before the outer sheath was pulled back.The issue occurred outside the patient.There were no patient complications.The procedure was completed with another of the same device.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9369200
MDR Text Key174190166
Report Number2134265-2019-14378
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/19/2019
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 Date12/17/2022
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0023969230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received11/25/2019
Supplement Dates Manufacturer Received12/12/2019
Supplement Dates FDA Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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