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

Catalog Number	RONYX30008UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Occlusion (1984)
Date of Event	02/28/2019
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, 5 resolute onyx drug eluting stents were implanted; three in the rca and two in the lad.The following day, patient suffered elevated cardiac enzymes with no treatment carried out.Patient recovered.Cec adjudicated event as a non-q wave mi of the target vessel, 3rd udmi peri pci.Cec assessment commented that there was a large side branch occlusion.Investigator assessed the event is not related to device or anti platelet.Sponsor assessed event is possibly related to device but not related to anti platelet.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9552208
• Report Number: 9612164-2020-00073
• Device Sequence Number: 1953764
• Product Code: NIQ
• UDI-Device Identifier: 00643169556966
• UDI-Public: 00643169556966
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/06/2020

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: 10/23/2020
• Device Catalogue Number: RONYX30008UX
• Device Lot Number: 0009396802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/06/2020
• 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: 62 YR
• Patient Weight: 127