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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING
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MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number RONYX25012UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 10/12/2019
Type of Reportable Event Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
During index procedure, a resolute onyx drug-eluting stent was implanted in the lad.Approximately 9 months post procedure, patient suffered congestive heart failure and died.Death was classified as a non-sudden cardiac death.The investigator assessed the event as not related to the device or anti platelet medication.Sponsor assessed event is possibly related to device and anti platelet medication.Investigator assessed event is not related to device or anti platelet medication.
 
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Brand Name
RESOLUTE ONYX RX
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
MDR Report Key9731647
Report Number9612164-2020-00802
Device Sequence Number2401673
Product Code NIQ
UDI-Device Identifier00643169556799
UDI-Public00643169556799
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P16043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date09/07/2020
Device Model NumberRONYX25012UX
Device Catalogue NumberRONYX25012UX
Device Lot Number0009316214
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/06/2020
Initial Report FDA Received Date02/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
Patient Weight74
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