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

Model Number RONYX30008UX

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

Patient Problems Death (1802); Stenosis (2263); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/06/2020

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 drug eluting stents were implanted in the lad.Approximately 12 months later the patient suffered death from cardiopulmonary failure.Death was classified as non-sudden cardiac death.The investigator and the sponsor assessed the event as not related to the device or anti-platelet medication.Safety commented death.

Manufacturer Narrative

Additional information: cec adjudicated death as cardiac due to aortic stenosis/heart failure.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: 9784715
• MDR Text Key: 181909325
• Report Number: 9612164-2020-00986
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556966
• UDI-Public: 00643169556966
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2020
• Device Model Number: RONYX30008UX
• Device Catalogue Number: RONYX30008UX
• Device Lot Number: 0009278298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Date Device Manufactured: 08/14/2018
• 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
• Patient Age: 83 YR
• Patient Weight: 63