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

Model Number	RONYX25030UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/10/2019
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 rca.Approximately 21 days post index procedure, patient suffered from acute cva.The investigator and safety assessed that the event was not related to index device or anti-platelet medication.The patient recovered.
Additional Manufacturer Narrative
Additional information: cec adjudicated the event as stroke, ischemic.Correction: patient is recovering.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Patient recovered.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: 9127539
• Report Number: 9612164-2019-04117
• Device Sequence Number: 3169554
• Product Code: NIQ
• UDI-Device Identifier: 00643169556843
• UDI-Public: 00643169556843
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2021

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: 04/13/2020
• Device Model Number: RONYX25030UX
• Device Catalogue Number: RONYX25030UX
• Device Lot Number: 0009084980
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/07/2019; 03/25/2021
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/15/2019; 04/19/2021
• 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: 60 YR
• Patient Weight: 110