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

Model Number	RONYX25022UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101)
Date of Event	05/08/2019
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 stents were implanted - one into the 1st diagonal and one into the lad.During a staged procedure four resolute onyx stents were implanted into the rca.Approx 5 months post staged procedure the patient suffered nstemi of the rca and total occlusion of the rca.The patient received a left heart cath and was treated with medication.The investigator and safety assessed the event as not related to the index device or anti-platelet medication.The patient recovered.
Additional Manufacturer Narrative
The investigator assessed the event as possibly related to the index device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the site (investigator) assessed the event as not related to the index device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: cec adjudicated the event date as (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec adjudicated the event as late stent thrombosis, arc definite in the rca and that it is related to the study stent.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: 8844910
• Report Number: 9612164-2019-03132
• Device Sequence Number: 11274706
• Product Code: NIQ
• UDI-Device Identifier: 00643169556829
• UDI-Public: 00643169556829
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 04/06/2020

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: 09/10/2020
• Device Model Number: RONYX25022UX
• Device Catalogue Number: RONYX25022UX
• Device Lot Number: 0009320711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 10/02/2019; 10/09/2019; 03/11/2020
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 10/01/2019; 10/09/2019; 02/20/2020; 04/06/2020
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 100