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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 Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2023
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter phone: (b)(6).
 
Event Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified carotid dissection.An 8.0-29 carotid wallstent was advanced for treatment.However, a high tension was encountered when advancing the stent, then it got kinked and could not be delivered smoothly.The stent was removed from the patient intact, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.
 
Manufacturer Narrative
Initial reporter phone: (b)(6).Device evaluated by mfr.: carotid wallstent monorail 8.0-29 was received for analysis.A visual examination found the stent of the device to be fully deployed from the device.The deployed stent was not returned for analysis.There were no issues identified with the tip of the device.A visual and tactile inspection identified no kinks or damage to the delivery system.
 
Event Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified carotid dissection.An 8.0-29 carotid wallstent was advanced for treatment.However, a high tension was encountered when advancing the stent, then it got kinked and could not be delivered smoothly.The stent was removed from the patient intact, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.
 
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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 Key17962453
MDR Text Key326322753
Report Number2124215-2023-54146
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 11/15/2023
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 Number0030878957
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2023
Initial Date FDA Received10/18/2023
Supplement Dates Manufacturer Received10/31/2023
Supplement Dates FDA Received11/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2023
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 Age74 YR
Patient SexFemale
Patient Weight60 KG
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