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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. RESOLUTE ONYX STENT DRUG-ELUTING CORONARY STENT SYSTEM

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MEDTRONIC, INC. RESOLUTE ONYX STENT DRUG-ELUTING CORONARY STENT SYSTEM Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2020
Event Type  malfunction  
Event Description
Stent thrombosis. Fda safety report id# (b)(4).
 
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Brand NameRESOLUTE ONYX STENT
Type of DeviceDRUG-ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key9695234
MDR Text Key178961457
Report NumberMW5092927
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 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 02/10/2020 Patient Sequence Number: 1
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