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

Catalog Number RONYX20030X

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

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Heart Failure (2206)

Event Date 02/12/2018

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During index procedure, three resolute onyx drug eluting stents were implanted in the lmca to lad and one resolute onyx drug eluting stent was implanted in the circumflex.On the same day, patient developed intra-procedure bradycardia and hypotension, which was treated with ventilation and intra-aortic balloon pump.Five days post index procedure, patient developed acute decompensated heart failure and was kept on ventilation.Eleven days post index procedure, patient developed refractory cardiogenic shock as a result of heart failure and hospital acquired pneumonia or ventilation acquired pneumonia.The following day, patient expired, cause of death was assessed as non-sudden cardiac death.Investigator assessed event is not related to the study device or antiplatelet.

Manufacturer Narrative

Patient also had infection (salmonella bacterium) which led to death.The investigator and sponsor assessed the infection event as not related to the device or antiplatelet medication.The cec has adjudicated the event as cardiac 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: 7453839
• MDR Text Key: 106264924
• Report Number: 9612164-2018-00854
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2019
• Device Catalogue Number: RONYX20030X
• Device Lot Number: 0008811108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Date Device Manufactured: 09/26/2017
• 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: 68