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

Model Number	RONYX25038UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Insufficient Information (4580)
Date of Event	05/22/2020
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, a resolute onyx drug-eluting stent was implanted in the lad.Approximately 34 months post procedure, patient death occurred.The death classification is unknown, patient died in sleep.Sponsor assessed event is not related to device or anti platelet medication.
Additional Manufacturer Narrative
Additional information: death was reported as due to natural causes, per the death certificate patient was morbidly obese, suffered from coronary artery disease, diabetes, hypertension and obstructive sleep apnea.The patient passed away in his sleep.No autopsy was conducted.The investigator assessed the event as not related to the antiplatelet medication and possibly related to the device.The sponsor assessed the event as possibly related to the device.Cec adjudicated death as cardiac.Cec adjudicated possible stent thrombosis (arc).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: 10481287
• Report Number: 9612164-2020-03270
• Device Sequence Number: 19681823
• Product Code: NIQ
• UDI-Device Identifier: 00643169556867
• UDI-Public: 00643169556867
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 05/17/2019
• Device Model Number: RONYX25038UX
• Device Catalogue Number: RONYX25038UX
• Device Lot Number: 0008636479
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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: 55 YR
• Patient Weight: 157