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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 Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2020
Event Type  malfunction  
Event Description
It was reported that the stent was unable to be reconstrained.A 10.0-31 carotid wallstent was selected for a procedure in the carotid artery lesion.During the procedure after 3mm of the stent was released, repositioning was desired.The stent was unable to be reconstrained.The device was pulled out from the patient's body and a new carotid wallstent was used.The procedure was successfully completed and there were no patient complications.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was received with the stent partially deployed on the delivery system.A visual and microscopic examination found the distal stent wires to be damaged.This type of damage is consistent with excessive force being applied to the device.The investigator could not fully constrain the stent due to the damage to the distal stent wires.A visual and tactile inspection of the device found no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the stent was unable to be reconstrained.A 10.0-31 carotid wallstent was selected for a procedure in the carotid artery lesion.During the procedure after 3mm of the stent was released, repositioning was desired.The stent was unable to be reconstrained.The device was pulled out from the patient's body and a new carotid wallstent was used.The procedure was successfully completed and there were no patient complications.
 
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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 Key10943002
MDR Text Key219489878
Report Number2134265-2020-16915
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,foreig
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/29/2024
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0026271402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Date Manufacturer Received12/14/2020
Patient Sequence Number1
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