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

Catalog Number	RONYX27515UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Injury (2348)
Date of Event	02/20/2019
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, two resolute onyx drug-eluting stents were implanted; one in the circumflex and other in the lad.Thirty-two days post procedure, nstemi of the target vessel was reported and treated with medication and revascularization with a drug-eluting stent implanted in the lad.Investigator assessed event is not related to the device and antiplatelets.Sponsor assessed event is possibly related to the device and unlikely related to the antiplatelets.Patient recovered.
Additional Manufacturer Narrative
Cec assessed myocardial infarction as a non q wave mi (target vessel), 3rd udmi spontaneous.Cec assessed revascularisation as a target vessel revascularisation, percutaneous intervention not involving the target lesion that was clinically driven.Cec commented tvr for both lad and diagonal.Stent is patent.Cec assessed stent thrombosis as no event.Cec commented the diagonal was jailed.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: 8447543
• Report Number: 9612164-2019-01017
• Device Sequence Number: 354820
• Product Code: NIQ
• UDI-Device Identifier: 00643169556898
• UDI-Public: 00643169556898
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/08/2019

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: 05/27/2020
• Device Catalogue Number: RONYX27515UX
• Device Lot Number: 0009159511
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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: Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 85