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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 26606
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2023
Event Type  malfunction  
Event Description
It was reported that removal difficulties were encountered.The approximately 85% stenosed target lesion was located in the mildly tortuous left internal carotid arteries.A 3.5mmx40mmx135cm (4f) sterling balloon catheter was advanced for pre-dilatation; however, slight friction was felt on the proximal side of the non-boston scientific guidewire while guiding the balloon catheter.A 6.0-22 carotid wallstent monorail was advanced for use.However, a slight friction was encountered while inserting the device into the patient's body.The device was removed, and subsequently, a 10.0-31 carotid wallstent monorail was also advanced.But a slight friction was also encountered while inserting the device into the patient's body.The process was continued, and both stents were successfully deployed.The system was then attempted to be removed from the body, but severe friction was felt that prevented the system from being easily pulled out.The procedure was completed with the original device.No patient complications were reported, and patient was in good condition post-procedure.
 
Event Description
It was reported that removal difficulties were encountered.The approximately 85% stenosed target lesion was located in the mildly tortuous left internal carotid arteries.A 3.5mmx40mmx135cm (4f) sterling balloon catheter was advanced for pre-dilatation; however, slight friction was felt on the proximal side of the non-boston scientific guidewire while guiding the balloon catheter.A 6.0-22 carotid wallstent monorail was advanced for use.However, a slight friction was encountered while inserting the device into the patient's body.The device was removed, and subsequently, a 10.0-31 carotid wallstent monorail was also advanced.But a slight friction was also encountered while inserting the device into the patient's body.The process was continued, and both stents were successfully deployed.The system was then attempted to be removed from the body, but severe friction was felt that prevented the system from being easily pulled out.The procedure was completed with the original device.No patient complications were reported, and patient was in good condition post-procedure.
 
Manufacturer Narrative
H6-component codes: corrected and updated from stent to catheter.Device evaluated by mfr: carotid wallstent monorail 10.0-31 was received for analysis.The following attributes were considered during analysis.This carotid device is recommended for use with a 0.014-inch (0.36mm) guidewire as per carotid wallstent instructions for use.During the product analysis a boston scientific 0.014-inch filterwire could not be advanced through the device due to the presence of solidified media within the wire lumen.The device was placed in a water bath at 27degrees in an attempt to soften the media.The investigator attempted to load the device on to the guidewire a second time but was unsuccessful.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no damage or issues with the delivery system.The device was returned with the stent fully deployed from the device.The deployed stent was not returned for analysis.
 
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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 Key17906643
MDR Text Key325709948
Report Number2124215-2023-54140
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeJA
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 11/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26606
Device Catalogue Number26606
Device Lot Number0030513165
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexMale
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