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

Lot Number 0010397918

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 02/05/2021

Event Type  Injury  

Event Description

Attempted to retrieve stent that did not deploy correctly.Unable to be removed and was wedged against artery wall.Fda safety report id# (b)(4).

• Brand Name: RESOLUTE ONYX CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC / MEDTRONIC IRELAND
• MDR Report Key: 11332535
• MDR Text Key: 232220837
• Report Number: MW5099394
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Lot Number: 0010397918
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization