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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 Activation, Positioning or Separation Problem (2906); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  malfunction  
Event Description
It was reported that stent migration occurred.The target lesion was located in the severely tortuous carotid artery.A 8.0-36 carotid wallstent was advanced for treatment.The stent reached the lesion; however, during deployment, it fell off downwards and was displaced.The stent was withdrawn and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
 
Event Description
It was reported that stent migration occurred.The target lesion was located in the severely tortuous carotid artery.A 8.0-36 carotid wallstent was advanced for treatment.The stent reached the lesion; however, during deployment, it fell off downwards and was displaced.The stent was withdrawn and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.As it was previously reported the device was "misplaced" but was able to be withdrawn, migration has been corrected to partial deployment.
 
Manufacturer Narrative
H6.Device codes: changed from migration to activation, positioning or separation problem.Device evaluated by manufacturer: the complaint device was received for analysis.The device was received with the stent in the correct position on the delivery system.The investigator successfully deployed the stent with a little resistance experienced due to the presence of solidified media within the delivery system.No damage was noted to 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.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.This concludes the product analysis.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12990755
MDR Text Key282199241
Report Number2134265-2021-15101
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 02/03/2022
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 Number0026920974
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2021
Initial Date FDA Received12/13/2021
Supplement Dates Manufacturer Received01/11/2022
Supplement Dates FDA Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2021
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 Age63 YR
Patient SexFemale
Patient Weight62 KG
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