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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 Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2022
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.An 8.0-29 carotid monorail stent was advanced for treatment.However, upon reaching the lesion, it was found that the stent was damaged.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: a carotid device was received for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent deployed from the delivery system.The stent was noted to be damaged.
 
Event Description
It was reported that stent damage occurred.An 8.0-29 carotid monorail stent was advanced for treatment.However, upon reaching the lesion, it was found that the stent was damaged.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key15660625
MDR Text Key306721290
Report Number2124215-2022-42181
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/16/2023
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 Number0028967537
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2022
Initial Date FDA Received10/24/2022
Supplement Dates Manufacturer Received05/29/2023
Supplement Dates FDA Received06/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2022
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 Age78 YR
Patient SexFemale
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