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

Model Number	RONYX25034UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	03/30/2019
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, one resolute onyx stent was implanted into the cx and two resolute onyx stents were implanted in the lad.On the same day, the patient suffered pci related mi.The investigator assessed the event as not related to the index device or anti-platelet medication.Safety assessed the event as possibly related to the index device but not related to the antiplatelet medication.
Additional Manufacturer Narrative
The cec adjudicated mi as no event, mi preceded procedure.The patient recovered.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: during the index procedure three resolute onyx stents were implanted in the lad.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: 8572323
• Report Number: 9612164-2019-01553
• Device Sequence Number: 263689
• Product Code: NIQ
• UDI-Device Identifier: 00643169556850
• UDI-Public: 00643169556850
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 03/03/2020

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: 05/01/2020
• Device Model Number: RONYX25034UX
• Device Catalogue Number: RONYX25034UX
• Device Lot Number: 0009123148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/30/2019; 04/17/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/25/2019; 03/03/2020
• 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
• Patient Age: 83 YR
• Patient Weight: 79