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

Catalog Number RONYX30018X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Pulmonary Edema (2020); Thrombus (2101)

Event Date 07/05/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

During the index procedure, two resolute onyx were implanted in the r-pav.On the same day, patient suffered acute pulmonary oedema.Patient was intubated and received medication.Investigator assessed that the event is unlikely related to index device or antiplatelets medication.Patient died - non sudden cardiac death.

Manufacturer Narrative

The patient has a medical history of hyperlipidemia and previous mi.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Cec assessed the event as cardiac death - cass site 1: 3 - dist rca stent thrombosis.Patient died within 24 hours of the procedure.Limited information but chart states that death is due to cardiogenic shock secondary to acute myocardial infarction - not clear if this is before procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the event was treated with pci.The death was reported by the investigator as a non-cardiac death.Sponsor assessed the event as not related to the device or antiplatelet medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information.Patient's weight.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The patient has a history of smoking, hypertension, diabetes, stroke.The index procedure was prompted by mi.During the index procedure two resolute onyx stents were implanted into the rca.Cec adjudicated the patients death was assessed as non sudden cardiac death.The investigator assessed the event (ae02- cardiogenic shock and death) as possibly related to the device and not related to anti-platelet medication.Safety assessed the event (ae02) as possibly related to the device and anti-platelet medication.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: 7705635
• MDR Text Key: 114534257
• Report Number: 9612164-2018-01805
• 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,Followup,Followup,Followup
• Report Date: 08/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2020
• Device Catalogue Number: RONYX30018X
• Device Lot Number: 0009029952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 08/16/2018; 08/08/2018; 12/04/2018; 04/03/2019; 04/03/2019; 08/01/2019
• Supplement Dates FDA Received: 09/04/2018; 10/02/2018; 12/14/2018; 04/30/2019; 04/30/2019; 08/20/2019
• Date Device Manufactured: 03/12/2018
• 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; Hospitalization; Other
• Patient Age: 81 YR
• Patient Weight: 61