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

Model Number	RONYX22515UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	06/10/2019
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 two resolute onyx des were implanted in the lad and three in the circumflex.Approximately two months post index procedure, patient suffered from myocardial infarction of a non-target vessel.Event was treated with coronary intervention.Investigator assessed that the event was not related to index device or anti-platelet medication.Safety assessed that the event was possibly related to index device, but not related to anti-platelet medication.Patient recovered.Cec adjudicated the mi end point as non-q-wave mi (vessel unknown), 3rd udmi spontaneous.Cec adjudicated the revascularization end point as no event and commented that no revascularization was performed.
Additional Manufacturer Narrative
Additional information: patient race updated.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: 9670923
• Report Number: 9612164-2020-00571
• Device Sequence Number: 16247815
• Product Code: NIQ
• UDI-Device Identifier: 00643169556713
• UDI-Public: 00643169556713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/25/2020

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: 04/03/2020
• Device Model Number: RONYX22515UX
• Device Catalogue Number: RONYX22515UX
• Device Lot Number: 0009062241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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: 71 YR
• Patient Weight: 77