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

Model Number RONYX22522UX

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

Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 04/12/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

During an index procedure four resolute onyx rx stents were implanted between the distal lad which had a chronic total occlusion and the prox lad which had no occlusion.Approximately 32 months later the patient suffered cardiogenic shock and chest pain.The patient was treated with medication.Within 24 hours the patient presented to er with w/c/o cp & sob; bradycardic followed by cardiac arrest.The patient died due to cardiogenic shock.Investigator assessed the event as possibly related to index device and anti-platelet medication.The sponsor assessed event as not related to the devices or antiplatelet medication.

Manufacturer Narrative

Additional information: the patient is a former smoker.The cec adjudicated the cardiac chest pain event as mi of unknown vessel occurred (b)(6) 2020).Cec also adjudicated possible stet thrombosis.Patient age and ethnicity are updated.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: 10447106
• MDR Text Key: 204159111
• Report Number: 9612164-2020-03120
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556737
• UDI-Public: 00643169556737
• 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
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2019
• Device Model Number: RONYX22522UX
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0008558962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Date Device Manufactured: 03/30/2017
• 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: 67 YR
• Patient Weight: 94