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

Catalog Number RONYX30038X

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

Patient Problem Death (1802)

Event Date 01/28/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

During index procedure, a resolute onyx drug-eluting stent was implanted in the circumflex.Approximately 17 months post procedure , patient suffered acute decompensated heart failure and was treated with medication.Approximately 2 weeks later, patient died.Death event is classified as a non-sudden cardiac death.Investigator and sponsor assessed event is not related to device or anti platelet medication.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10625339
• MDR Text Key: 209740596
• Report Number: 9612164-2020-03751
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 10/05/2020

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: 04/21/2020
• Device Catalogue Number: RONYX30038X
• Device Lot Number: 0009092018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/05/2020
• Date Device Manufactured: 04/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 84 YR
• Patient Weight: 103