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

Catalog Number	RONYX25008UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Stenosis (2263); Patient Problem/Medical Problem (2688)
Date of Event	08/07/2017
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, one resolute onyx drug eluting stents was implanted into the lad.Approximately 3 days post index procedure the patient suffered myocardial infarction in a non-target vessel.Stenosis in the lad was treated with a resolute onyx drug eluting stent.The event was resolved.The investigator assessed the event was not related to the study device.
Additional Manufacturer Narrative
During the index procedure, lcx was also treated with one resolute onyx stent.Cec assessed the event as a non q wave mi (target vessel), mdt extended historical spontaneous.The cec adjudicated the mi as no event.The revascularisation was assessed by the cec as tlr- percutaneous intervention clinically driven.Stent thrombosis was assessed as no event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Patient weight updated.Patient race and ethnicity provided.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: 7291922
• Report Number: 9612164-2018-00400
• Device Sequence Number: 10799001
• Product Code: NIQ
• UDI-Device Identifier: 00643169556782
• UDI-Public: 00643169556782
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2018

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: 03/22/2019
• Device Catalogue Number: RONYX25008UX
• Device Lot Number: 0008545690
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 11/13/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 11/16/2018; 12/07/2018
• 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: 76 YR
• Patient Weight: 83