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

Model Number ONYXNG30034UX

Device Problem Difficult to Flush (1251)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

During prep of the stent, one of the stent struts was not flush with the stent.This stent was removed and replaced with another stent - there was no patient harm.Manufacturer response for stent, onyx frontier coronary stent 3.0 mm x 34 mm (per site reporter) product handled by site.

• Brand Name: ONYX FRONTIER
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 15498453
• MDR Text Key: 300738310
• Report Number: 15498453
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ONYXNG30034UX
• Device Lot Number: 0011137435
• 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: 09/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1