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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
Catalog Number RONYX35022UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Occlusion (1984)
Date of Event 03/06/2019
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 lad.It was reported that on the same day there was a plaque shift from the lad to the 1st diagonal, post stent deployment.The patient recovered.The site assessed the event as not related to the anti-platelet medication and causally related to 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
MDR Report Key9347107
Report Number9612164-2019-04823
Device Sequence Number2972697
Product Code NIQ
UDI-Device Identifier00643169557093
UDI-Public00643169557093
Combination Product (Y/N)N
Initial Reporter StateFL
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) 11/20/2019
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 Date11/05/2020
Device Catalogue NumberRONYX35022UX
Device Lot Number0009421291
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2019
Initial Report FDA Received Date11/20/2019
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;
Patient Age66 YR
Patient Weight93
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