MAUDE Adverse Event Report: MEDTRONIC, INC. RESOLUTE ONYX¿; CORONARY DRUG-ELUTING STENT

Model Number RONYX20018UX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

During percutaneous coronary intervention, the stent pre-maturely came off the delivery catheter inside the patient's right coronary artery.It appeared as though the stent was stripped off the balloon catheter while attempting to cross through existing stent struts.The delivery catheter was removed and sequestered by me.A balloon catheter was used to crush the stent against the vessel wall and then covered the crushed stent with a new stent.Patient remained stable throughout the procedure.

• Brand Name: RESOLUTE ONYX¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy.; minneapolis MN 55432
• MDR Report Key: 9745109
• MDR Text Key: 180570128
• Report Number: 9745109
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2020,01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RONYX20018UX
• Device Catalogue Number: RONYX20018UX
• Device Lot Number: 0009363454
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA