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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC / MEDTRONIC IRELAND RESOLUTE ONYX CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT

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MEDTRONIC / MEDTRONIC IRELAND RESOLUTE ONYX CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0010397918
Device Problems Malposition of Device (2616); Activation, Positioning or SeparationProblem (2906)
Patient Problem Failure of Implant (1924)
Event Date 02/05/2021
Event Type  Injury  
Event Description
Attempted to retrieve stent that did not deploy correctly. Unable to be removed and was wedged against artery wall. Fda safety report id# (b)(4).
 
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Brand NameRESOLUTE ONYX CORONARY STENT SYSTEM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC / MEDTRONIC IRELAND
MDR Report Key11332535
MDR Text Key232220837
Report NumberMW5099394
Device Sequence Number1
Product Code NIQ
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 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0010397918
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

Patient Treatment Data
Date Received: 02/12/2021 Patient Sequence Number: 1
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