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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 Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Device evaluated by mfr.: an 8.0-29 carotid wallstent was returned for analysis.The device was received with the stent partially deployed on the delivery system.The stent could not be deployed due to a complete break of the outer shaft and solidified blood and media inside the delivery system.A visual and tactile inspection identified a complete break of the shaft of the device located approximately 180mm proximal of the guidewire port.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 24-jul-2020.It was reported that stent partial deployment occurred.The target lesion was located in the internal carotid artery.After an embolic protection device was placed and pre-dilatation was performed, an 8.0-29 carotid wallstent was advanced for treatment.However, during stent deployment, the stent was partially deployed and was unable to expand due to the strong resistance.Temporarily, it was re-sheathed and after induction was performed again, it was deployed but the condition was the same.The procedure was completed with another of the same device.No patient complications nor injuries reported.However, returned device analysis revealed the stent was partially deployed and there was a shaft break.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10356251
MDR Text Key201868826
Report Number2134265-2020-10282
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 company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 08/03/2020
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 Expiration Date09/11/2023
Device Model Number26606
Device Catalogue Number26606
Device Lot Number0025349056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/24/2020
Initial Date FDA Received08/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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