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

Model Number	RONYX35012UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombus (2101); Injury (2348)
Date of Event	10/10/2019
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 index procedure, a resolute onyx drug-eluting stent was implanted in the rca.Approximately 12 months post procedure, patient suffered in-stent restenosis which is reported to be related to stent thrombosis.Stent thrombosis in the target vessel rca confirmed by angio.Revascularization of the rca with the implantation of stent was carried out.Event unresolved.Investigator assessed event is possibly related to device and anti platelet medication.
Additional Manufacturer Narrative
Additional information: patient recovered.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event was treated with medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: patient was not on dapt 24 hours prior to the event.Additional information: cec adjudicated the event as non-q-wave mi (target vessel).Cec adjudicated the revascularization as tlr percutaneous intervention.Cec adjudicated the stent thrombosis end point as no event.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: 9206900
• Report Number: 9612164-2019-04416
• Device Sequence Number: 2950587
• Product Code: NIQ
• UDI-Device Identifier: 00643169557062
• UDI-Public: 00643169557062
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup,Followup
• Report Date (Section B): 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: RONYX35012UX
• Device Catalogue Number: RONYX35012UX
• Device Lot Number: 0008847455
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 12/10/2019; 02/25/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/13/2019; 01/07/2020; 02/27/2020
• 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; Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 75