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

Model Number	RONYX25018UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	01/05/2020
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 a procedure, four resolute onyx drug-eluting stents were implanted: three in the lad and one in the 1st diagonal.Approximately 10 months post procedure the patient suffered from acute respiratory distress syndrome due to bilateral pneumonia and ongoing sepsis.The event was treated with medication but the patient died approximately 5 days later.Acute respiratory distress syndrome was the primary cause of death and was assessed as not related to the device or anti-platelet medication by the investigator and sponsor.The death was classified as a non-cardiac death.The investigator assessed the sepsis as not related to study device or anti platelet medication and the sponsor assessed it as unlikely related to study device and not related to anti platelet medication.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 10990337
• Report Number: 9612164-2020-04866
• Device Sequence Number: 3478023
• Product Code: NIQ
• UDI-Device Identifier: 00643169556812
• UDI-Public: 00643169556812
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 09/15/2019
• Device Model Number: RONYX25018UX
• Device Catalogue Number: RONYX25018UX
• Device Lot Number: 0008796552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/11/2020
• 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
• Patient Age: 87 YR
• Patient Weight: 83