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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 Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2022
Event Type  malfunction  
Event Description
Reportable based on device analysis completed on 08-jul-2022.It was reported that tracking difficulties were encountered.The patient had right internal carotid artery occlusion and left carotid severe stenosis.The target lesion was located in the left carotid artery.After the filter wire was in placed, a 10.0-24 carotid wallstent was advanced for treatment.However, the tip of the device could not cross through the wire for many times.The physician removed and replaced the device with another of same device.The new stent could cross smoothly to reach the lesion position and was deployed well.The procedure was completed and there were no patient complications reported.The patient status was stable.However, returned device analysis revealed stent damage.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: a carotid device was returned for analysis.This carotid device is recommended for use with a 0.014 (0.36mm) guidewire.During the product analysis a boston scientific 0.014 filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no kinks along the shaft.The device was returned with the stent fully mounted in the correct location on the device.The outer sheath was retracted by approximately 3mm exposing the distal stent struts.As a results the distal struts were misaligned.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15161600
MDR Text Key304042734
Report Number2134265-2022-07952
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 08/03/2022
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 Number0028092897
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/08/2022
Initial Date FDA Received08/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2021
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 Age75 YR
Patient SexMale
Patient Weight55 KG
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