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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC VASCULAR RESOLUTE ONYX STENT ; CORONARY DRUG-ELUTING STENT

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MEDTRONIC VASCULAR RESOLUTE ONYX STENT ; CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Infusion or Flow Problem (2964)
Patient Problems Cardiomyopathy (1764); Thrombosis (2100); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 01/15/2020
Event Type  Death  
Event Description
Stent thrombosis.Hx 13 stents prior plus cardiomyopathy.Coded in cath lab after procedure.Long code resulting hypoperfusion.Safety report id# (b)(4).
 
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Brand Name
RESOLUTE ONYX STENT
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC VASCULAR
MDR Report Key9693533
MDR Text Key178748542
Report NumberMW5092881
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/10/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age71 YR
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