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

Catalog Number	RONYX27508UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombus (2101)
Date of Event	11/16/2017
Type of Reportable Event	Death
Event or Problem Description
The index procedure was prompted by unstable angina.During the index procedure two resolute onyx des were implanted in the 1st diagonal.Approximately 5 months post index procedure the patient had a mitral valve replacement, tricuspid valve repair and asd closure.This was treated with medication.The patient died from a non sudden cardiac death.The investigator reported that the event is not related to the index device.
Additional Manufacturer Narrative
The event term has been updated to cardiogenic shock.The patient suffered acute chronic heart failure requiring aggressive diuresis.The outcome was death.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient has a previous medical history of congestive heart failure.Cause of death reported as heart failure.Cec adjudicated the event as cardiac death.Cec adjudicated stent thrombosis as no event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient medical history also includes a.Fib and coronary artery disease.It was reported that the patient had left atrial appendage thrombus and lv aneurysm prior to death.If information is provided in the future, a supplemental report will be issued.

• 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: 7127952
• Report Number: 9612164-2017-02011
• Device Sequence Number: 2145221
• Product Code: NIQ
• UDI-Device Identifier: 00643169556874
• UDI-Public: 00643169556874
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/15/2019

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: 01/20/2019
• Device Catalogue Number: RONYX27508UX
• Device Lot Number: 0008459056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/16/2018; 12/05/2018; 02/14/2019
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/23/2018; 01/03/2019; 03/15/2019
• 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: Death
• Patient Age: 65 YR
• Patient Weight: 109