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

Model Number RONYX25012UX

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

Lost a stent during placement of coronary stents.Unable to visualize the stent where the intended placement should be.Stent not visualized on delivery balloon after removal either.Unable to find stent anywhere on operative table, equipment or in the patient.Surgeon aware and used flouroscopy to scan the entirety of the patient.Still unable to visualize stent anywhere in patient's body.Surgeon finished the case and disclosed to patient possibility of retained item.

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 14944433
• MDR Text Key: 295415047
• Report Number: 14944433
• 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: 07/05/2022,06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX25012UX
• Device Catalogue Number: RONYX25012UX
• Device Lot Number: 0011094497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2022
• Date Report to Manufacturer: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Female
• Patient Weight: 82 KG