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

Model Number	RONYX25018UX
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic resolute onyx zotarolimus eluting stent too small for lesion, longer stent chosen.

• Brand Name: RESOLUTE ONYX
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11580943
• Report Number: 11580943
• Device Sequence Number: 4846441
• Product Code: NIQ
• UDI-Device Identifier: 00643169556812
• UDI-Public: (01)00643169556812(17)220904(10)0010367493
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/26/2021
• Report Date (Section F): 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
• Operator of Device: Health Professional
• Device Model Number: RONYX25018UX
• Device Lot Number: 0010367493
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1
• Patient Weight: 80
• Date Report Sent to FDA: 03/26/2021