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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 Positioning Failure (1158); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2024
Event Type  malfunction  
Event Description
It was reported that the stent system was stuck and had to be removed from the patient forcefully.This carotid wallstent self-expanding stent was selected for angioplasty treatment of the carotid.The procedure was being performed to treat 75% stenosis, and the target lesion contained moderate calcification and no tortuosity.During the deployment of the stent, it was impossible to deploy the stent and impossible to retract.The physician decided the best option was to forcefully pull the whole system (stent, guide, and introducer) together.The procedure was able to be completed successfully using another device without sequela.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).
 
Event Description
It was reported that the stent system was stuck and had to be removed from the patient forcefully.This carotid wallstent self-expanding stent was selected for angioplasty treatment of the carotid.The procedure was being performed to treat 75% stenosis, and the target lesion contained moderate calcification and no tortuosity.During the deployment of the stent, it was impossible to deploy the stent and impossible to retract.The physician decided the best option was to forcefully pull the whole system (stent, guide, and introducer) together.The procedure was able to be completed successfully using another device without sequela.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).Device eval by manufacturer: a visual and tactile examination identified no issues with the catheter or delivery system.The device was returned with the stent already deployed from the delivery system.The deployed stent was not returned with the device.The device encountered difficult patient anatomy as the lesion was 75% stenosed, which was located in a moderately tortuous vessel, which could have contributed to the difficulty in deploying the stent.It is unknown when the stent was deployed from the delivery system; however, further information from the field thought it was stuck on the launcher or outside when the physician pulled the whole system.
 
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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 Key18817223
MDR Text Key337572705
Report Number2124215-2024-11665
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
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 Number0028945647
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
014 FILTERWIRE; 014 FILTERWIRE
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