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

Model Number RONYX35018UX

Device Problems Fracture; Detachment of Device or device Component

Event Date 11/13/2019

Event Type  Malfunction  

• 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: 9361240
• Report Number: 9612164-2019-04852
• Device Sequence Number: 1
• Product Code: NIQ
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/22/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: RONYX35018UX
• Device Catalogue Number: RONYX35018UX
• Device LOT Number: 0009837501
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 07/23/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial