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

Catalog Number RONYX25008UX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Thrombus (2101)

Event Date 11/16/2017

Event Type  Death  

Event Description

The index procedure was prompted by unstable angina.During the index procedure two resolute onyx des were implanted in the 1st diagonal.Approximately 5 months post index procedure the patient had a mitral valve replacement, tricuspid valve repair and asd closure.This was treated with medication.The patient died from a non sudden cardiac death.The investigator reported that the event is not related to the index device.

Manufacturer Narrative

The event term has been updated to cardiogenic shock.The patient suffered acute chronic heart failure requiring aggressive diuresis.The outcome was death.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The patient has a previous medical history of congestive heart failure.Cause of death reported as heart failure.Cec adjudicated the event as cardiac death.Cec adjudicated stent thrombosis as no event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient medical history also includes a.Fib and coronary artery disease.It was reported that the patient had left atrial appendage thrombus and lv aneurysm prior to death.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7127956
• MDR Text Key: 95159009
• Report Number: 9612164-2017-02010
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2019
• Device Catalogue Number: RONYX25008UX
• Device Lot Number: 0008480278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2019
• Date Device Manufactured: 02/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 109