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

Model Number RONYX40022UX

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

Patient Problems Occlusion (1984); Thrombus (2101); Injury (2348)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a revascularization, 2 resolute onyx des were implanted in the rca, on the same day of the first revascularization, a second revascularization was performed and 2 resolute onyx des were implanted, one in the rca and one in the 2nd rpl.Approximately 9 months post first and second revascularization, during a third revascularization was performed and two resolute onyx des were implanted in the rca.It was reported that during the revascularization, patient suffered from thrombus in the rca causing an abrupt closure of the rca.Event was successfully treated with a medtronic bms.Safety assessed that the event was not related to index device, but possibly related to antiplatelets medication.Patient recovered.

Manufacturer Narrative

Additional information: the investigator assessed the event as not related to the device or 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: 9596138
• MDR Text Key: 175218719
• Report Number: 9612164-2020-00272
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557185
• UDI-Public: 00643169557185
• 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: 01/31/2020

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: 08/12/2021
• Device Model Number: RONYX40022UX
• Device Catalogue Number: RONYX40022UX
• Device Lot Number: 0009862328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/31/2020
• Date Device Manufactured: 08/13/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 101