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

Model Number RONYX25018UX

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Event Description

Medtronic resolute onyx zotarolimus eluting stent too small for lesion, longer stent chosen.

• 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: 11580943
• MDR Text Key: 242699752
• Report Number: 11580943
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556812
• UDI-Public: (01)00643169556812(17)220904(10)0010367493
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX25018UX
• Device Lot Number: 0010367493
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 80