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

Model Number	RONYX45030UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/20/2020
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 the index procedure three resolute onyx des were implanted in the 2nd obtuse marginal.Two days later during a staged procedure, three resolute onyx des were implanted; two in the ramus and one in the lcma.Approximately 20 months later, the patient suffered cardiogenic shock, severe mitral regurgitation, worsening renal failure and died.Death was classified as non sudden cardiac death.Investigator and sponsor assessed the event as not related to index device or 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 ; IE
• MDR Report Key: 10127337
• Report Number: 9612164-2020-02123
• Device Sequence Number: 3282668
• Product Code: NIQ
• UDI-Device Identifier: 00643169557284
• UDI-Public: 00643169557284
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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: 03/14/2020
• Device Model Number: RONYX45030UX
• Device Catalogue Number: RONYX45030UX
• Device Lot Number: 0009035479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/08/2020
• 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; Hospitalization; Life Threatening; Other; Disability
• Patient Age: 77 YR
• Patient Weight: 104