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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 26665
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2022
Event Type  malfunction  
Event Description
It was reported that stent profile problem occurred.The 7mm target lesion was located in carotid artery.A 10x37,5.9f,135cm carotid wallstent stent was implanted.However, the device was elongated above the length of 70mm.The procedure was completed.No patient complications were reported and the patient condition was good.
 
Manufacturer Narrative
B5- describe event or problem: updated.
 
Event Description
It was reported that stent profile problem occurred.The 7mm target lesion was located in carotid artery.A 10x37,5.9f,135cm carotid wallstent stent was implanted.However, the device was elongated above the length of 70mm.The procedure was completed.No patient complications were reported and the patient condition was good.It was further reported that the target lesion was 70% stenosed, 40mm in length, moderately tortuous and mildly calcified.The diameter of the target lesion had a size discrepancy (4mm-7mm).The stent was deployed and elongated beyond its indicated size.The physician decided to leave the stent inside the patient.
 
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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 Key15329009
MDR Text Key301680299
Report Number2124215-2022-31337
Device Sequence Number1
Product Code NIM
UDI-Device Identifier08714729781141
UDI-Public08714729781141
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P050019
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 10/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26665
Device Catalogue Number26665
Device Lot Number0026927789
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2021
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 SexMale
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