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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 Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/15/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The 8 mm x 49 mm lesion target lesion was located in the right carotid artery.A 10.0-31mm carotid wallstent was implanted for treatment.However, the stent part was observed to be bent, but was implanted.During post dilation with a 5mm sterling balloon catheter, resistance on the edge of the stent was felt but was able to cross with guide wire assistance.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was received with the stent fully deployed from the delivery system as it was implanted inside the patient.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.No kinks or damage was identified with the delivery system.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues along the length of the device.No issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.The 8 mm x 49 mm lesion target lesion was located in the right carotid artery.A 10.0-31mm carotid wallstent was implanted for treatment.However, the stent part was observed to be bent, but was implanted.During post dilation with a 5mm sterling balloon catheter, resistance on the edge of the stent was felt but was able to cross with guide wire assistance.No patient complications were reported.
 
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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 Key9985886
MDR Text Key188881778
Report Number2134265-2020-05402
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 06/09/2020
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 Date06/05/2023
Device Model Number26606
Device Catalogue Number26606
Device Lot Number0024880534
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2020
Initial Date Manufacturer Received 04/15/2020
Initial Date FDA Received04/22/2020
Supplement Dates Manufacturer Received06/03/2020
Supplement Dates FDA Received06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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