MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS MEDTRONIC RESOLUTE ONYX DES; CORONARY DRUG-ELUTING STENT

Model Number RONYX25012UX

Device Problems Break (1069); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 12/24/2020

Event Type  malfunction  

Event Description

A 26 cm of a distal section of a stent balloon catheter broke off during procedure.The broken segment obtained within the guide catheter.The guide catheter, balloon catheter, and wire were removed as a unit while exerting suction at the hub with a syringe.The broken segment was retrieved intact and saved.

• Brand Name: MEDTRONIC RESOLUTE ONYX DES
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS
• MDR Report Key: 11107910
• MDR Text Key: 225119030
• Report Number: MW5098610
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Model Number: RONYX25012UX
• Device Lot Number: 0010356636
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 72