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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); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2023
Event Type  malfunction  
Event Description
It was reported that stent partial deployment, difficult to reconstrain and removal difficulties occurred.The 75% stenosed target lesion was located in cervical segment of carotid artery.An 8.0-29 carotid wallstent was advanced for treatment.However, after it was deployed for 25%, the stent was stuck inside the delivery sheath and could not be deployed nor be withdrawn.The entire system was removed, and it was noted that the stent still could not be advanced nor withdrawn outside the patient.The procedure was completed after dilation with a balloon and no other stent was placed.There were no patient complications nor injuries reported, and the patient was stable post procedure.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).
 
Event Description
It was reported that stent partial deployment, difficult to reconstrain and removal difficulties occurred.The 75% stenosed target lesion was located in cervical segment of carotid artery.An 8.0-29 carotid wallstent was advanced for treatment.However, after it was deployed for 25%, the stent was stuck inside the delivery sheath and could not be deployed nor be withdrawn.The entire system was removed, and it was noted that the stent still could not be advanced nor withdrawn outside the patient.The procedure was completed after dilation with a balloon and no other stent was placed.There were no patient complications nor injuries reported, and the patient was stable post procedure.It was further reported that, the target lesion was mildly tortuous and non-calcified.It was noted that the stent was removed not fully reconstrained and could not be resecured due to damage and could not be recovered.Future procedure was also rescheduled.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6) medical.E1: initial reporter phone: (b)(6).Device evaluated by mfr.: carotid wallstent monorail 8.0-29 was received for analysis.A visual and tactile examination identified a complete detachment of the outer sheath of the device located at the main t-valve.This type of damage is consistent with excessive force being applied to the device when attempting deployment.The device was returned with the stent partially deployed on the delivery system.The exposed distal wires of the partially deployed stent were noted to be damaged.The investigator was unable to deploy or re-constrain the stent due to a separation of the outer sheath of the device.
 
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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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17354705
MDR Text Key319443310
Report Number2124215-2023-38059
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2023
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 Number0030917410
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2023
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 Age77 YR
Patient Weight66 KG
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