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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 Break (1069); Positioning Failure (1158); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2023
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The patient presented with right common carotid artery entrapment and underwent stenting.A 10.0-37 carotid wallstent was advanced for treatment.However, during introduction, resistance was encountered.After reaching the target lesion, it was found that the outer sheath was fractured and 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.
 
Manufacturer Narrative
Device evaluated by mfr.: carotid wallstent monorail 10.0-37 was received for analysis.The device was received with the stent fully constrained in the correct position on the delivery system.The investigator successfully deployed the stent without issue.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 shaft separation or damage along the length of the device.
 
Event Description
It was reported that shaft break occurred.The patient presented with right common carotid artery entrapment and underwent stenting.A 10.0-37 carotid wallstent was advanced for treatment.However, during introduction, resistance was encountered.After reaching the target lesion, it was found that the outer sheath was fractured and 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.
 
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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 Key16517727
MDR Text Key311084448
Report Number2124215-2023-08648
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 04/27/2023
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 Number0028895186
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/20/2023
Initial Date FDA Received03/09/2023
Supplement Dates Manufacturer Received04/05/2023
Supplement Dates FDA Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2022
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 Age48 YR
Patient Weight62 KG
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