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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 Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2019
Event Type  Injury  
Event Description
It was reported that shaft detachment occurred.The target lesion was located in the stenosed right common carotid artery.An 8.0-29mm carotid wallstent was advanced to treat the lesion.However, the device could not cross the stenosis.Upon removal, the delivery shaft was fractured.The detached portion contained the stent and remained over the opened filter placed in the internal carotid artery.Surgical intervention was performed to remove the detached device.No further patient complications were reported.
 
Event Description
It was reported that shaft detachment occurred.The target lesion was located in the stenosed right common carotid artery.An 8.0-29mm carotid wallstent was advanced to treat the lesion.However, the device could not cross the stenosis.Upon removal, the delivery shaft was fractured.The detached portion contained the stent and remained over the opened filter placed in the internal carotid artery.Surgical intervention was performed to remove the detached device.No further patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned in two pieces with the filterwire still attached to the distal outer.The device was returned to the complaint investigation site with the stent fully constrained in the device.No issues were noted with the constrained stent.A visual and microscopic investigation identified no issues with the tip that could have contributed to the complaint incident.A visual and tactile examination of the device identified an inner/outer shaft break at the guidewire exit port 210mm from distal end of valve body.No issues were identified during the product analysis.
 
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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
MDR Report Key8931093
MDR Text Key155522604
Report Number2134265-2019-10229
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/10/2022
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0023158571
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2020
Date Manufacturer Received03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
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