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

Model Number	RONYX20008UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/08/2020
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, four resolute onyx drug-eluting stents were implanted in the rca.Seven medtronic pta balloons were also used during procedure.Approximately 32 months post procedure, patient suffered unstable angina with known coronary artery disease and was treated with change in medication.A month later, patient expired.Death is of unknown classification.Investigator and sponsor assessed event is not related to device or anti platelet medication.
Additional Manufacturer Narrative
Additional information: 3 of the resolute onyx des were not implanted in the index procedure but in a later revascularization 14 months post index procedure to treat the 2nd diagonal, graft rca and lad.The event occurred 18 months post implant of these devices.Implant date provided.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The death event is classed as a non-sudden cardiac death.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: 10074214
• Report Number: 9612164-2020-01919
• Device Sequence Number: 16824046
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 05/14/2020
• Device Model Number: RONYX20008UX
• Device Catalogue Number: RONYX20008UX
• Device Lot Number: 0009139981
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 11/16/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/08/2020; 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: 84 YR
• Patient Weight: 59