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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC CARDIA PROMUS ELITE 3.00X 20MM / STENT CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC CARDIA PROMUS ELITE 3.00X 20MM / STENT CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 25234974
Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/08/2020
Event Type  Malfunction  
Event Description

In process of fixing the right coronary artery, the stent was not able to be advanced in the coronary artery and it was decided to retract the stent. In the process of retracting the stent, the stent was dislodged at the level of the radial artery. Vascular surgeon was consulted and stent was left alone on the wall as it was stuck and not moving. Fda safety report id# (b)(4).

 
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Brand NameBOSTON SCIENTIFIC CARDIA PROMUS ELITE 3.00X 20MM / STENT
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key10142821
MDR Text Key195002358
Report NumberMW5094940
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 06/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT Number25234974
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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