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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 RONYX40012UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 04/30/2020
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 the index procedure one resolute onyx des was implanted in the 1st obtuse marginal.Approximately 15 months later, the patient suffered paroxysmal supraventricluar tachycardia treated with catheter ablation but a sudden cardiac death occurred.The investigator and the sponsor assessed the event as not related to the anti-platelet medication or the device.
 
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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 Key10060434
Report Number9612164-2020-01883
Device Sequence Number3514774
Product Code NIQ
UDI-Device Identifier00643169557154
UDI-Public00643169557154
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
P160043
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) 05/15/2020
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 Date05/24/2020
Device Model NumberRONYX40012UX
Device Catalogue NumberRONYX40012UX
Device Lot Number0009159758
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/01/2020
Initial Report FDA Received Date05/15/2020
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; Required Intervention;
Patient Age52 YR
Patient Weight122
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