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

Model Number	RONYX35018UX
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient's status post percutaneous coronary intervention (pci) of saphenous vein grafts (svg) to patent ductus arteriosus (pda).Complicated by undelpoyed stent stuck in the soft tissue in the groin, needed manual pressure.Cross over angio did not show any complications.Hematoma after sitting up and eating now under control, pressure applied for 30 min.Fem stop applied with no pressure, distal pulses well felt.

• Brand Name: RESOLUTE ONYX
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 10378475
• Report Number: 10378475
• Device Sequence Number: 11236935
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: (01)00643169557086
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/22/2020
• Report Date (Section F): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: RONYX35018UX
• Device Catalogue Number: (240)RONYX35018UX
• Device Lot Number: (10)0010251213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 40
• Date Report Sent to FDA: 07/22/2020