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

Model Number	RONYX25015UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/13/2019
Type of Reportable Event	Death
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 in the rca.Approximately 11 months post procedure, patient expired.The cause of death is unknown.Sponsor assessed event is possibly related to device and anti platelet medication.Death was classified as sudden cardiac death.It was stated that patient was not taking the medication regularly and using the nebulizer more frequently than recommended which could have led to cardiac arrest.It was also reported that patient still heavily smoked cigarettes which likely contributed to patient's death.Investigator assessed that the event was not related to antiplatelets medication and unlikely related to index device.Cec adjudicated the death as a cardiac death.Cec commented possible stent thrombosis, sudden death 1 yr post stent.The possible stent thrombosis occurred in 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: 9762225
• Report Number: 9612164-2020-00898
• Device Sequence Number: 16838780
• Product Code: NIQ
• UDI-Device Identifier: 00643169556805
• UDI-Public: 00643169556805
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: 03/06/2020
• Device Model Number: RONYX25015UX
• Device Catalogue Number: RONYX25015UX
• Device Lot Number: 0009024405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/27/2020
• 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: Death
• Patient Age: 73 YR
• Patient Weight: 125