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

Model Number RONYX20012UX

Device Problem Separation Failure (2547)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

Physician inserted stent into diagonal artery.Stent balloon was inflated.When balloon was deflated the stent was not visible on x-ray.Stent was found to have remained on the stylet when it was removed for insertion and was found on sterile field.No harm came to patient, and nothing was left in the body that was not intended to be.

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 14394164
• MDR Text Key: 291608849
• Report Number: 14394164
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RONYX20012UX
• Device Catalogue Number: RONYX20012UX
• Device Lot Number: (10)0010814168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2022
• Date Report to Manufacturer: 05/13/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1