MAUDE Adverse Event Report: MEDTRONIC INC, -SWINNEA ONYX FRONTIER; CORONARY DRUG-ELUTING STENT

Model Number	ONYXNG30015UX
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device packaging opened.The stent delivery system for implantation was prepared.The physician saw that the stent itself was fractured before proceeding.

• Brand Name: ONYX FRONTIER
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC INC, -SWINNEA; 5300 airways blvd; memphis TN 38116
• MDR Report Key: 20223834
• Report Number: 20223834
• Device Sequence Number: 7202447
• Product Code: NIQ
• UDI-Device Identifier: 00763000511470
• UDI-Public: 0100763000511470172606191000118325412001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/08/2024
• Report Date (Section F): 05/08/2024

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 Model Number: ONYXNG30015UX
• Device Catalogue Number: ONYXNG30015UX
• Device Lot Number: 00118325412001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/08/2024