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

Catalog Number	RONYX25034UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Embolism (1829); Thrombus (2101)
Date of Event	01/20/2019
Type of Reportable Event	Death
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 cx and one into the lad.It was reported that five days post index procedure, the patient suffered pulmonary embolism.The pi reported a known rv thrombus.It was reported that the patient went into pea arrest.The patient was treated with medication and compression's but passed away.The investigator and safety assessed the event as not related to the index device or anti-platelet medication.
Additional Manufacturer Narrative
Additional information: sponsor assessed the event as possibly related to the anti-platelet medication.Cec adjudicated death as cardiac.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient has a medical history of aortic stenosis and lv dysfunction.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: 8353655
• Report Number: 9612164-2019-00577
• Device Sequence Number: 11334703
• Product Code: NIQ
• UDI-Device Identifier: 00643169556850
• UDI-Public: 00643169556850
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/23/2019

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: 03/05/2020
• Device Catalogue Number: RONYX25034UX
• Device Lot Number: 0009023011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 03/06/2019; 05/02/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/03/2019; 05/23/2019
• 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: Death; Other
• Patient Age: 59 YR
• Patient Weight: 75