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

Model Number RONYX35012UX

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

Patient Problems Myocardial Infarction (1969); Thrombus (2101); Injury (2348)

Event Date 10/10/2019

Event Type  Injury  

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 rca.Approximately 12 months post procedure, patient suffered in-stent restenosis which is reported to be related to stent thrombosis.Stent thrombosis in the target vessel rca confirmed by angio.Revascularization of the rca with the implantation of stent was carried out.Event unresolved.Investigator assessed event is possibly related to device and anti platelet medication.

Manufacturer Narrative

Additional information: patient recovered.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Event was treated with medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: patient was not on dapt 24 hours prior to the event.Additional information: cec adjudicated the event as non-q-wave mi (target vessel).Cec adjudicated the revascularization as tlr percutaneous intervention.Cec adjudicated the stent thrombosis end point as no event.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: 9206900
• MDR Text Key: 163007649
• Report Number: 9612164-2019-04416
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557062
• UDI-Public: 00643169557062
• 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,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: RONYX35012UX
• Device Catalogue Number: RONYX35012UX
• Device Lot Number: 0008847455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 11/12/2019; 12/10/2019; 02/25/2020
• Supplement Dates FDA Received: 11/13/2019; 01/07/2020; 02/27/2020
• Date Device Manufactured: 10/23/2017
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 75