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 Code	Myocardial Infarction (1969)
Date of Event	07/28/2017
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
The index procedure was prompted by stable angina and an mi.During the index procedure, two resolute onyx des were implanted into the proximal cx.Approximately 18 days post index procedure, the patient suffered an nstemi.The event was treated with a pci of the svg-diag.The patient recovered on the same day.It is unknown if the event is related to the study device.
Additional Manufacturer Narrative
The event is not related to the study device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The cec adjudicated the event as a non q wave mi (non target vessel), mdt extended historical spontaneous-no event.The cec also adjudicated the stent thrombosis as no event.The patient has a medical history of arrhythmia.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec assessed mi as non q wave mi (non target vessel), mdt extended historical spontaneous.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec assessed the revascularisation as a non tvr surgery.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec readjudicated the revascularisation as a non tvr percutaneous intervention of the graft 1st diag.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient has a medical history of chronic left bundle branch block and tia.As well as the cec already assessing the mi as non q wave mi (non target vessel), mdt extended historical spontaneous, the cec also adjudicated the mi as no scai event.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: 6819730
• Report Number: 9612164-2017-01163
• Device Sequence Number: 65486
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/01/2019

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: 03/10/2019
• Device Catalogue Number: RONYX25008UX
• Device Lot Number: 0008532059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/15/2017; 10/18/2018; 10/18/2018; 01/31/2019; 01/31/2019; 03/22/2019; 04/02/2019
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/04/2017; 11/16/2018; 11/16/2018; 02/28/2019; 02/28/2019; 04/19/2019; 05/01/2019
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 64