MAUDE Adverse Event Report: MEDTRONIC IRELAND RESULUTE ONYX STENT; CORONARY DRUG-ELUTING STENT

Model Number RONYX40008UX

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

Stent slipped on balloon while trying to place in left main vessel.This makes it unsafe to deploy, and had to be removed from the body.No issues or complications as a result.

• Brand Name: RESULUTE ONYX STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 13860307
• MDR Text Key: 287684634
• Report Number: 13860307
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX40008UX
• Device Catalogue Number: RONYX40008UX
• Device Lot Number: 0010735960
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Female