MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING

Model Number	RONYX30015UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	05/22/2019
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 index procedure, a resolute onyx drug-eluting stent was implanted in the lad and an euphora pta balloon was also used during procedure.Same day patient suffered elevated cardiac enzymes.Patient recovered.Cec adjudicated non-q wave mi of the target vessel lad medtronic extended historical peri-pci and scai definition peri-pci.Investigator assessed event is unlikely related to the device and anti platelet medication.Sponsor assessed event is not related to device or anti platelet medication.

• 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 Key: 10625330
• Report Number: 9612164-2020-03750
• Device Sequence Number: 2605040
• Product Code: NIQ
• UDI-Device Identifier: 00643169556980
• UDI-Public: 00643169556980
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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 Date: 04/11/2021
• Device Model Number: RONYX30015UX
• Device Catalogue Number: RONYX30015UX
• Device Lot Number: 0009693329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR
• Patient Weight: 83