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

Model Number	RONYX30034UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Occlusion (1984)
Date of Event	02/28/2019
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
It was reported that during the index procedure, one resolute onyx drug eluting stent was implanted in the lad.6 days post index, the patient suffered nstemi, the target vessel was not involved.It was reported that the 2nd diagonal vessel was occluded but no pci was carried out.The patient was treated with medication for shortness of breath.The patient recovered.The investigator and sponsor assessed that the event was not related to the device or anti-platelet drug.
Additional Manufacturer Narrative
Additional information: sponsor assessment was updated to possibly related to index device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated that the mi occurred in the 2nd obtuse marginal.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: 9201726
• Report Number: 9612164-2019-04399
• Device Sequence Number: 14210907
• Product Code: NIQ
• UDI-Device Identifier: 00643169557031
• UDI-Public: 00643169557031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 06/11/2020
• Device Model Number: RONYX30034UX
• Device Catalogue Number: RONYX30034UX
• Device Lot Number: 0009184064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 02/15/2020; 02/13/2020
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 02/25/2020; 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: 71 YR
• Patient Weight: 79