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

Model Number	RONYX27518UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	11/12/2019
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, two resolute onyx drug-eluting stents were implanted: one in the cx and one in the lad.Approximately seven months post procedure, patient suffered coronary artery disease.Patient had severe three vessel (rca,lcx and lad) cad/aortic stenosis and cabg was carried out to treat the stenosis.In stent stenosis was reported in the cx and lad.Patient recovered.Investigator assessed event is not related to device or anti platelet medication.Sponsor assessed event is possibly related to device but not related to anti platelet medication.Cec assessed event is a non-q wave mi of target vessel, 3rd udmi spontaneous.Cec also adjudicated the revascularisation as tl cabg clinically driven revascularization of the cx and lad and non-target vessel surgery, clinically driven revascularisation of the rca.

• 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: 9834281
• Report Number: 9612164-2020-01174
• Device Sequence Number: 19592350
• Product Code: NIQ
• UDI-Device Identifier: 00643169556904
• UDI-Public: 00643169556904
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/16/2020

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: 10/29/2020
• Device Model Number: RONYX27518UX
• Device Catalogue Number: RONYX27518UX
• Device Lot Number: 0009410979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/16/2020
• 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; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 118