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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); Difficult to Remove (1528); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Event Description
It was reported that removal difficulties occurred.The 90% stenosed target lesion was located in the neck.A 10.0-31 carotid wallstent monorail stent was advanced for treatment.However, during the procedure, the device could not be pull or push smoothly.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
 
Event Description
It was reported that removal difficulties occurred.The 90% stenosed target lesion was located in the neck.A 10.0-31 carotid wallstent monorail stent was advanced for treatment.However, during the procedure, the device could not be pull or push smoothly.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the stent was not fully deployed and fully reconstrained prior to removal.The stent and sheath were then retracted into the guide catheter and pulled out of the body together.
 
Manufacturer Narrative
B5.Describe event or problem- updated.H6 device codes- updated.
 
Manufacturer Narrative
Device evaluated by mfr.: a carotid device was returned for analysis; the following attributes were examined during 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 already deployed from the device.The deployed stent was not returned with the device.
 
Event Description
It was reported that removal difficulties occurred.The 90% stenosed target lesion was located in the neck.A 10.0-31 carotid wallstent monorail stent was advanced for treatment.However, during the procedure, the device could not be pull or push smoothly.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the stent was not fully deployed and fully reconstrained prior to removal.The stent and sheath were then retracted into the guide catheter and pulled out of the body together.
 
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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 Key15624252
MDR Text Key302326971
Report Number2124215-2022-41884
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,Followup
Report Date 12/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2022
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 Number0029053310
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2022
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 Age63 YR
Patient SexFemale
Patient Weight51 KG
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