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

Model Number	RONYX22518UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)
Date of Event	04/12/2020
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 an index procedure four resolute onyx rx stents were implanted between the distal lad which had a chronic total occlusion and the prox lad which had no occlusion.Approximately 32 months later the patient suffered cardiogenic shock and chest pain.The patient was treated with medication.Within 24 hours the patient presented to er with w/c/o cp & sob; bradycardic followed by cardiac arrest.The patient died due to cardiogenic shock.Investigator assessed the event as possibly related to index device and anti-platelet medication.The sponsor assessed event as not related to the devices or antiplatelet medication.
Additional Manufacturer Narrative
Additional information: the patient is a former smoker.The cec adjudicated the cardiac chest pain event as mi of unknown vessel occurred ((b)(6) 2020).Cec also adjudicated possible stet thrombosis.Patient age and ethnicity are updated.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: 10447121
• Report Number: 9612164-2020-03121
• Device Sequence Number: 19662359
• Product Code: NIQ
• UDI-Device Identifier: 00643169556720
• UDI-Public: 00643169556720
• 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: 2017
• 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): 11/30/2020

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: 04/04/2019
• Device Model Number: RONYX22518UX
• Device Catalogue Number: RONYX22518UX
• Device Lot Number: 0008569494
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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: 67 YR
• Patient Weight: 94