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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 RONYX30015UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event 08/28/2020
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 des was implanted in the lad.Approximately 21 months post index procedure, patient suffered from melena.Patient was on dapt 24 hours prior to event.Investigator assessed that the event was not related to index device, but possibly related to antiplatelets medication.Patient is not recovered.
 
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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 Key10905231
Report Number9612164-2020-04608
Device Sequence Number2713570
Product Code NIQ
UDI-Device Identifier00643169556980
UDI-Public00643169556980
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 Year2018
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) 11/25/2020
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 Date03/30/2020
Device Model NumberRONYX30015UX
Device Catalogue NumberRONYX30015UX
Device Lot Number0009057612
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/05/2020
Initial Report FDA Received Date11/25/2020
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 Hospitalization;
Patient Age79 YR
Patient Weight62
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