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

Model Number	RONYX30034UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	10/28/2019
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 the index procedure one resolute onyx drug eluting stent was implanted in the cx.Approximately 11 months later the patient presented with mid-sternal aching and constant chest pain.The patient was hospitalized and treated with medication and revascularization of the lad and cx.The patient recovered.The site assessed the event as not related to anti-platelet medication or the device.The sponsor assessed the event as not related to the anti-platelet medication and possibly related to the device.Cec adjudicated the event as mi involving the lad and cx (target vessel).Cec adjudicated the revascularization as tlr percutaneous intervention involving the cx and non-tvr revascularization involving the lad.

• 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: 10822058
• Report Number: 9612164-2020-04373
• Device Sequence Number: 3680460
• Product Code: NIQ
• UDI-Device Identifier: 00643169557031
• UDI-Public: 00643169557031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: 04/09/2020
• Device Model Number: RONYX30034UX
• Device Catalogue Number: RONYX30034UX
• Device Lot Number: 0009076599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/11/2020
• 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; Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 111