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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 RONYX35030UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pneumonia (2011)
Date of Event 05/13/2020
Type of Reportable Event Serious Injury
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 drug eluting stent was implanted in the 1st obtuse marginal.Approximately 14 months post procedure patient suffered varicella pneumonia.The event was treated with medication.The patient did not recover.
 
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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
EI 
MDR Report Key11618048
Report Number9612164-2021-01315
Device Sequence Number4365084
Product Code NIQ
UDI-Device Identifier00643169557116
UDI-Public00643169557116
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P160043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/06/2021
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 Date06/09/2019
Device Model NumberRONYX35030UX
Device Catalogue NumberRONYX35030UX
Device Lot Number0008671558
Was Device Available for Evaluation? No
Type of Report(Section G)Fifteen-Day
Initial Date Received by Manufacturer 03/09/2021
Initial Report FDA Received Date04/06/2021
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 Hospitalization; Other;
Patient Age68 YR
Patient Weight59
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