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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 Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2022
Event Type  malfunction  
Event Description
It was reported that removal difficulties were encountered.Vascular access was obtained via femoral artery.The target lesion was located in the moderately tortuous and mildly calcified carotid artery.An 8.0-21 carotid wallstent was advanced for treatment.However, during procedure the stent was partially deployed.When the physician was trying to re-sheath the stent it was neither being reconstrained nor being deployed.Finally, a guide catheter recaptured the device and removed successfully.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: a carotid device was received for analysis.A visual and tactile examination identified that the stainless-steel handle was advanced fully into the device.The shaft was detached at the guidewire port.The device was received with the stent on the correct location on the device.No issues noted with the stent.This concludes the product analysis.
 
Event Description
It was reported that removal difficulties were encountered.Vascular access was obtained via femoral artery.The target lesion was located in the moderately tortuous and mildly calcified carotid artery.An 8.0-21 carotid wallstent was advanced for treatment.However, during procedure the stent was partially deployed.When the physician was trying to re-sheath the stent it was neither being reconstrained nor being deployed.Finally, a guide catheter recaptured the device and removed successfully.The procedure was completed with another of same device.No patient complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15640445
MDR Text Key302096808
Report Number2124215-2022-41128
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0029169167
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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