MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS RESOLUTE ONYX; CORONARY DRUG-ELUTING STENT

Model Number RONYX22538UX

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

Elderly male with history of chronic heart failure, coronary artery disease, diabetes, and hypertension.Having a percutaneous transluminal coronary angioplasty.After rotoblade in circ, stent inserted and stuck.It did not deploy.The stent delivery system was removed, and the stent was not on the balloon.The stent was lodged and traveled to left anterior descending.A snare was used to retrieve the stent.Original procedure was not completed, echo was done.Patient discharged 2 days later without known injury.

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis MN 55428
• MDR Report Key: 10476240
• MDR Text Key: 205126489
• Report Number: 10476240
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX22538UX
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0010173383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 88