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

Model Number	RONYX27526UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombus (2101); Injury (2348)
Date of Event	09/04/2018
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
Index procedure was prompted by positive stress test.During index procedure, a resolute onyx drug-eluting stent was implanted in the lad.Approximately 14 months post procedure, patient suffered myocardial infarction of the target vessel and was treated with revascularization.Sponsor assessed event is not related to device or anti platelet medication.
Additional Manufacturer Narrative
Additional information: during the revascularization procedure two resolute onyx drug eluting stents were implanted (unknown vessel) and one nc euphora balloon catheter was used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: there was no treatment of the mi with pci.Mi was not related to the target vessel.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: balloon angioplasty was carried out to treat 100% in-stent restenosis in the lcx.The late stent thrombosis occurred prior to the revascularization.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the investigator assessed the event as possibly related to the anti-platelet medication and not related to the device.Event was treated with medication and pci.Cec adjudicated the event as a non-q-wave mi of a non-target vessel, mdt extended historical spontaneous.Cec discovery late stent thrombosis.Correction: the patient recovered.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: 9144340
• Report Number: 9612164-2019-04181
• Device Sequence Number: 16799809
• Product Code: NIQ
• UDI-Device Identifier: 00643169556928
• UDI-Public: 00643169556928
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/27/2020

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: 04/21/2019
• Device Model Number: RONYX27526UX
• Device Catalogue Number: RONYX27526UX
• Device Lot Number: 0008595285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/15/2019; 01/02/2020; 02/06/2020; 02/03/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/05/2019; 01/24/2020; 02/18/2020; 02/27/2020
• 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; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 84