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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); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2024
Event Type  malfunction  
Manufacturer Narrative
E1 - (b)(6).
 
Event Description
It was reported that positioning difficulty and shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified in the origin of the left internal carotid artery.A 10.0-31 carotid wallstent was advanced for treatment.However, during deployment, the location was not good and so the stent was recaptured.During the second attempt on deployment, the stent was unable to deploy at all.The delivery system was removed from the guiding catheter.After removal, it was noted that the sheath was fractured, and the stent could not be delivered.The procedure was completed with a different device.There were no complications reported and the patient status was stable.
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter city: (b)(6).The device was returned for evaluation.A visual and tactile examination identified a complete separation of the outer sheath of the device located approximately 170mm proximal of the guidewire port.The sheath was also found to be severely kinked at approximately 20mm proximal of the mounted stent.This type of damage is consistent with excessive force being applied to the device, in particular when attempting deployment.No other issues were noted with the delivery system.The device was returned with the stent in the correct position on the delivery system.It is not possible to deploy the stent due to kinking and a separation of the outer sheath of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that positioning difficulty and shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified in the origin of the left internal carotid artery.A 10.0-31 carotid wallstent was advanced for treatment.However, during deployment, the location was not good and so the stent was recaptured.During the second attempt on deployment, the stent was unable to deploy at all.The delivery system was removed from the guiding catheter.After removal, it was noted that the sheath was fractured, and the stent could not be delivered.The procedure was completed with a different 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 Key18767566
MDR Text Key336113052
Report Number2124215-2024-05551
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
Report Date 02/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2024
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 Number0031736517
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2023
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 Age71 YR
Patient SexMale
Patient Weight60 KG
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