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

Model Number	RONYX30030UX
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary artery disease, hypertension and chest pain.While having a heart cath procedure, the onyx stent buckled on itself when attempting to place it in the target vessel.Removed without known complications.Procedure was heart cath, left stent percutaneous transluminal coronary angioplasty (ptca).It was successfully removed without known complication.Another 3.0 x 30 onyx stent was deployed in its place.Discharged home the following day.

• Brand Name: RESOLUTE ONYX
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10424870
• Report Number: 10424870
• Device Sequence Number: 3025864
• Product Code: NIQ
• UDI-Device Identifier: 00643169557024
• UDI-Public: (01)00643169557024(17)220226(10)0010155436
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/11/2020
• Report Date (Section F): 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RONYX30030UX
• Device Catalogue Number: (240)RONYX30030UX
• Device Lot Number: 0010155436
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80
• Date Report Sent to FDA: 08/11/2020