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

Model Number	RONYX40030UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/10/2020
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 the index procedure two resolute onyx des were implanted; one in the l-pda and one in the circumflex.Two resolute onyx des were implanted during a revasc procedure, one in the cx and one in the om.Approximately 31 months post index procedure the patient suffered chest discomfort with exertion.Patient was hospitalized and ptca with brachytherapy of the cx carried out.A non-medtronic balloon was used.Patient recovered.The investigator and the sponsor assessed the event as not related to the anti-platelet medication or the device.Stent thrombosis in the circumflex (cass #19) was confirmed by angio.Event was treated with poba.Cec adjudicated the event as tlr percutaneous intervention of the cx.

• 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: 10873998
• Report Number: 9612164-2020-04514
• Device Sequence Number: 4329411
• Product Code: NIQ
• UDI-Device Identifier: 00643169557208
• UDI-Public: 00643169557208
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/20/2020

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: 04/29/2020
• Device Model Number: RONYX40030UX
• Device Catalogue Number: RONYX40030UX
• Device Lot Number: 0009066319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/20/2020
• 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; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 98