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

Model Number	RONYX40018UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Injury (2348)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: revascularisation to treat the mi was carried out ((b)(6) 2020).The patient has a history of smoking, mi, pci, cabg, hyperlipidemia, hypertension, atrial fibrillation, diabetes and unstable angina.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.
Event or Problem Description
During index procedure, two resolute onyx drug-eluting stents were implanted; one in the 1st diagonal and cx.Approximately 13 months post procedure, patient suffered nstemi in a target vessel (lad) and was treated with a resolute onyx des implanted in the 1st diagonal.Investigator assessed event is possibly related to device but unlikely related to anti platelet medication.Sponsor assessed event is unlikely related to device and anti platelet medication.Patient recovered.

• 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: 9755865
• Report Number: 9612164-2020-00876
• Device Sequence Number: 2288989
• Product Code: NIQ
• UDI-Device Identifier: 00643169557178
• UDI-Public: 00643169557178
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 04/02/2020
• Device Model Number: RONYX40018UX
• Device Catalogue Number: RONYX40018UX
• Device Lot Number: 0009059706
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/02/2020
• 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: 70 YR
• Patient Weight: 108