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

Model Number	RONYX27515UX
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male to emergency department with active chest pain.During the heart cath, stent did deploy but the balloon did not deflate.No known harm to patient.

• 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: 10332039
• Report Number: 10332039
• Device Sequence Number: 17049751
• Product Code: NIQ
• UDI-Device Identifier: 00643169556898
• UDI-Public: (01)00643169556898(17)220201(10)0010119946
• 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): 07/15/2020
• Report Date (Section F): 07/15/2020

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: RONYX27515UX
• Device Lot Number: 0010119946
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 07/15/2020