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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 Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the stent was returned partially deployed from the delivery system.The distal stent wires were noted to be damaged.This type of damage is consistent with the stent encountering resistance during deployment.The stent was successfully deployed with some resistance due to solidified media within the delivery system.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 15-dec-2020.It was reported that stent failure to deploy occurred.The 80% stenosed target lesion was located in the severely tortuous common carotid artery.A 10.0-31 carotid wallstent monorail stent was advanced but failed to deploy.When the device was removed and checked outside the patient's body, it was noticed that there was a considerable resistance during deployment.The procedure was completed with a different device.There were no patient complications reported.However, returned device analysis revealed that the distal stent struts were damaged.
 
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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 Key11038236
MDR Text Key222394250
Report Number2134265-2020-18091
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 12/18/2020
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 Date12/09/2023
Device Model Number26606
Device Catalogue Number26606
Device Lot Number0025576148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2020
Initial Date FDA Received12/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age61 YR
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