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

Model Number	RONYX40012UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	12/10/2017
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 stent was implanted in the 1st diagonal to treat a de novo lesion.Approximately 4 months post index procedure, the patient suffered non-stemi.It was reported that the patient presented chest pain and elevated troponin.The event was treated with percutaneous intervention.The investigator assessed that the event was not related to index device or antiplatelets medication.The event is unresolved.
Additional Manufacturer Narrative
Event is resolved.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: cec did not assess this mi event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec assessed the revascularisation procedure as a non tvr pci.The first vessel to show signs of mi, stent thrombosis or revascularization was the proximal cx.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient has a medical history of atrial fibrilation, atrial flutter, previous mi and cad.The event was treated with ballooning of the lcx.The cec assessed the mi as no event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec assessed mi as no event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the sponsor assessed that the event was not related to index device.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: 7420753
• Report Number: 9612164-2018-00783
• Device Sequence Number: 13470370
• Product Code: NIQ
• UDI-Device Identifier: 00643169557154
• UDI-Public: 00643169557154
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/06/2021

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: 01/05/2019
• Device Model Number: RONYX40012UX
• Device Catalogue Number: RONYX40012UX
• Device Lot Number: 0008438949
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 01/15/2019; 01/31/2019; 01/31/2019; 01/31/2019; 12/19/2020
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 05/24/2018; 01/31/2019; 02/13/2019; 02/13/2019; 02/27/2019; 01/06/2021
• 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: 74