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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 Positioning Failure (1158); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: device was received for analysis.This carotid device is recommended for use with a 0.014in (0.36mm) guidewire.During the product analysis a boston scientific 0.014in filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified a complete detachment of the outer shaft of the device located approximately distal of the main t-valve.This type of damage is consistent with excessive force being applied to the device when attempting deployment.The device was returned with the stent in the correct position on the device.The investigator was unable to deploy the stent due to a break in the outer shaft of the device.
 
Event Description
Reportable based on device analysis completed on 10-jan-2023.It was reported that the device was difficult to track over wire and failed to deploy.The 85% stenosed target lesion was located in the moderately calcified and severely tortuous carotid artery.A 8.0-29 carotid wallstent was advanced over wire.However, resistance was felt during introduction.Upon reaching the target lesion, the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed a detached outer shaft.
 
Manufacturer Narrative
Device evaluated by manufacturer: device was received for analysis.This carotid device is recommended for use with a 0.014in (0.36mm) guidewire.During the product analysis a boston scientific 0.014in filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified a complete detachment of the outer shaft of the device located approximately distal of the main t-valve.This type of damage is consistent with excessive force being applied to the device when attempting deployment.The device was returned with the stent in the correct position on the device.The investigator was unable to deploy the stent due to a break in the outer shaft of the device.
 
Event Description
Reportable based on device analysis completed on 10-jan-2023.It was reported that the device was difficult to track over wire and failed to deploy.The 85% stenosed target lesion was located in the moderately calcified and severely tortuous carotid artery.A 8.0-29 carotid wallstent was advanced over wire.However, resistance was felt during introduction.Upon reaching the target lesion, the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed a detached outer shaft.The initial report was submitted in error.Per device investigation, the outer shaft break was located 45mm distal of the main t-valve which is not reportable as this portion cannot enter the body and is unlikely to result in a serious injury or death if the malfunction were to recur.
 
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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 Key16196914
MDR Text Key308583850
Report Number2124215-2023-01839
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCH
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 01/19/2023
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 Model Number26605
Device Catalogue Number26605
Device Lot Number0029397239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2023
Initial Date FDA Received01/18/2023
Supplement Dates Manufacturer Received01/10/2023
Supplement Dates FDA Received01/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age82 YR
Patient SexFemale
Patient Weight65 KG
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