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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); Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
Event Description
It was reported that partial deployment and stent could not be fully re-constrained, and shaft break occurred.The patient underwent stenting of the 70% stenosed target lesion located in the mildly tortuous and moderately calcified right internal carotid artery.Following non-boston scientific (bsc) balloon dilatation, vessel dissection occurred.A non boston scientific distal access catheter was advanced into the c2-c4 segment of the carotid artery along a non-boston scientific guidewire.An 8.0-36 carotid wallstent was advanced for treatment.However, during deployment, resistance was encountered, and the stent could not be completely deployed and 40% of the stent was deployed.An 8f guide catheter was used to recapture the intermediate tube system.After withdrawal, the stent delivery shaft and the intermediate tube were fractured.The stent could not be fully re-constrained.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.
 
Manufacturer Narrative
The carotid device was received for analysis, inserted in a guide catheter.The guide catheter was noted to be damaged.A visual and tactile examination identified that the outer shaft has detached at the distal edge of the main t-valve.The stainless-steel shaft is noted to be damaged.The device was received with the stent partially deployed from the delivery system.The distal end stent wires were noted to damaged.No other issues were identified during the product analysis.
 
Event Description
It was reported that partial deployment and stent could not be fully re-constrained, and shaft break occurred.The patient underwent stenting of the 70% stenosed target lesion located in the mildly tortuous and moderately calcified right internal carotid artery.Following non-boston scientific (bsc) balloon dilatation, vessel dissection occurred.A non boston scientific distal access catheter was advanced into the c2-c4 segment of the carotid artery along a non-boston scientific guidewire.An 8.0-36 carotid wallstent was advanced for treatment.However, during deployment, resistance was encountered, and the stent could not be completely deployed and 40% of the stent was deployed.An 8f guide catheter was used to recapture the intermediate tube system.After withdrawal, the stent delivery shaft and the intermediate tube were fractured.The stent could not be fully re-constrained.The procedure was completed with another of same device.There were no 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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18924133
MDR Text Key337905472
Report Number2124215-2024-11256
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 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
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 Number0032324777
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE: SYNCHRO.; GUIDEWIRE: SYNCHRO.
Patient Age62 YR
Patient SexMale
Patient Weight60 KG
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