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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 Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Event Description
It was reported that stent positioning problem occurred.The 60-70% stenosed target lesion was located in the mildly tortuous and moderately calcified carotid artery.An 8.0-21 carotid wallstent was advanced to treat the lesion.However, during stent deployment, the stent jumped about 1mm.The procedure was completed with this device.There were no patient complications reported.
 
Event Description
It was reported that stent positioning problem occurred.The 60-70% stenosed target lesion was located in the mildly tortuous and moderately calcified carotid artery.An 8.0-21 carotid wallstent was advanced to treat the lesion.However, during stent deployment, the stent jumped about 1mm.The procedure was completed with this device.There were no patient complications reported.It was further reported that the target lesion was 70-80% stenosed and was severely calcified.It was noted that the stent migrated just after deployment.
 
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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 Key11728566
MDR Text Key247515009
Report Number2134265-2021-05122
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 05/18/2021
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 Date08/21/2021
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0021765445
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/08/2021
Initial Date FDA Received04/26/2021
Supplement Dates Manufacturer Received04/28/2021
Supplement Dates FDA Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
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