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

Model Number	RONYX35034UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	03/09/2019
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 index procedure, a resolute onyx drug eluting stent was implanted in rca.Approximately one month post procedure, patient suffered hypertensive crisis and was treated with medication.Patient recovered.Cec adjudicated the event an non-q wave mi 3rd udmi spontaneous of the target vessel.Investigator and sponsor assessed event is not related to device or anti platelet medication.
Additional Manufacturer Narrative
Additional information: cec adjudication was updated to mi - vessel unknown.Cec commented that the pda stenosis is unchanged.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: 9640977
• Report Number: 9612164-2020-00457
• Device Sequence Number: 2928317
• Product Code: NIQ
• UDI-Device Identifier: 00643169557123
• UDI-Public: 00643169557123
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/24/2020

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: 04/12/2020
• Device Model Number: RONYX35034UX
• Device Catalogue Number: RONYX35034UX
• Device Lot Number: 0009083155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/24/2020
• 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: 81 YR
• Patient Weight: 95