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

Catalog Number	RONYX25034UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Patient Problem/Medical Problem (2688)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the index procedure the 1st lpl was treated with a resolute onyx des.The distal cx was treated with resolute onyx des.The lesion was further treated by another resolute onyx des.Approximately 3 weeks post index procedure the patient suffered a nstemi.The patient was hospitalized.The investigator reported that the event had a probable relationship to the index device.Stent thrombosis was confirmed by angio but the device was a non mdt stent.
Additional Manufacturer Narrative
The nstemi was treated with stenting and ballooning of the distal lcx.The patient received a change in medication as treatment for this event.The patient recovered.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It was reported that symptoms and biomarkers do not support definition of spontaneous mi.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The cec has adjudicated that the mi is not an event.The cec adjudicated term for the revascularization is tlr percutaneous intervention - clinically driven.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
During the index procedure the l-pda was treated not the lpl.The cec adjudicated term is tlr percutaneous intervention not involving tl - clinically driven.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Updated cec adjudication: cec event definition tlr- percutaneous intervention- clinically driven.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction to aware date/date mfr rec for previously submitted additional information from (b)(6) 2017 to (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient has a medical history of aortic valve replacement.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec adjudicated non q-wave mi (target vessel) mdt extended historical spontaneous.The investigator assessed that the event is possibly related to the anti-platelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient has a medical history of cad.The index procedure was also prompted by positive stress test.One sprinter legend balloon was used to post dilate.The mi occurred in the cx.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: 7003131
• Report Number: 9612164-2017-01543
• Device Sequence Number: 16375529
• Product Code: NIQ
• UDI-Device Identifier: 00643169556850
• UDI-Public: 00643169556850
• 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: 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): 04/02/2019

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: 01/26/2019
• Device Catalogue Number: RONYX25034UX
• Device Lot Number: 0008471151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 01/08/2018; 02/15/2018; 03/19/2018; 04/24/2018; 10/09/2017; 10/09/2018; 10/18/2018; 03/08/2019; 03/11/2019
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 01/31/2018; 03/14/2018; 03/30/2018; 05/24/2018; 11/06/2018; 11/13/2018; 11/16/2018; 03/11/2019; 04/02/2019
• 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: 69 YR
• Patient Weight: 129