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

Catalog Number	RONYX27530UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	02/25/2019
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 coronary des was implanted in the lad.Approximately three months later the patient presented with increasing chest pain and was diagnosed with a non stemi (vessel unknown).Cardiac enzymes were up and were trending up pre procedure.The patient was treated with non target vessel pci by stenting the rca.The investigator assessed the event as not related to the device and not related to the antiplatelet medication.Sponsor assessed the event as not related to the device and not related to the antiplatelet medication.The patient recovered.
Additional Manufacturer Narrative
Additional information: target vessel was not involved in the mi.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: 8568028
• Report Number: 9612164-2019-01523
• Device Sequence Number: 11349419
• Product Code: NIQ
• UDI-Device Identifier: 00643169556935
• UDI-Public: 00643169556935
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 04/14/2020
• Device Catalogue Number: RONYX27530UX
• Device Lot Number: 0009085220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 76