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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS; STENT, CAROTID

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BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS; STENT, CAROTID Back to Search Results
Catalog Number 71-902
Device Problem Positioning Failure (1158)
Patient Problem No Information (3190)
Event Date 05/01/2015
Event Type  malfunction  
Event Description
The device would not track over wire and the stent deployed prematurely.Stent did not deploy in patient, but could have caused a stroke.
 
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Brand Name
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key4787214
MDR Text Key16862461
Report Number4787214
Device Sequence Number1
Product Code NIM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 05/04/2015
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 Invalid Data
Device Catalogue Number71-902
Device Lot Number17268613
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/04/2015
Event Location Hospital
Date Report to Manufacturer05/21/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/04/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EZ-190CM FILTER WIRE WAS IN PLACE AT TIME
Patient Age70 YR
Patient Weight101
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