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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10675
Device Problem Fracture
Event Date 01/06/2020
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. Vascular access was obtained via the radial artery. The 90% stenosed, 24mm x 3. 5mm, concentric, de novo target lesion was located in the moderately calcified and mildly tortuous left anterior descending artery (lad). After successful pre-dilatation of the lesion with a 2. 5mm balloon, a 28 x 3. 00 promus elite was advanced to the target lesion and deployed. A stent fracture was noted during deployment due to the moderate calcium. The stent was not fully deployed and was not well apposed and was removed. The procedure was not completed due to this event. No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.

 
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Brand NamePROMUS ELITE
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
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 johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9654770
Report Number2134265-2020-00693
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10675
Device Catalogue Number10675
Device LOT Number0023697607
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/31/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/23/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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