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); Patient Problem/Medical Problem (2688)
Date of Event	07/11/2018
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
During the index procedure, one resolute onyx drug eluting stent was implanted into the lad.Approximately 1 year post index procedure, the patient suffered non-stemi (mi) in the lad.This was treated with target vessel revascularization of the lad.The investigator assessed the event as not related to the index device or anti-platelet medication.Sponsor assessed the revascularization as a tvr.
Additional Manufacturer Narrative
The patient was also treated with medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the patient had a family history of cvd/cad.Cec adjudicated non-q wave mi (vessel unknown) mdt extended historical spontaneous.Tvr-percutaneous intervention not involving tl - not clinically driven.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec adjudicated tvr-percutaneous intervention not involving tl as clinically driven.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: 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: 7772238
• Report Number: 9612164-2018-02017
• Device Sequence Number: 1011810
• Product Code: NIQ
• UDI-Device Identifier: 00643169556928
• UDI-Public: 00643169556928
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/20/2020

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: 03/03/2019
• Device Model Number: RONYX27526UX
• Device Catalogue Number: RONYX27526UX
• Device Lot Number: 0008516020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 11/27/2018; 04/18/2019; 07/24/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/03/2018; 12/20/2018; 05/14/2019; 02/20/2020
• 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: 64 YR
• Patient Weight: 79