MAUDE Adverse Event Report: MEDTRONIC IRELAND DES RESOLUTE ONYX; DOSE CORONARY DRUG ELUTING STENT

Model Number RONYYX20015UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 03/16/2019

Event Type  Injury  

Event Description

Dislodged cardiac stent during coronary intervention.

• Brand Name: DES RESOLUTE ONYX
• Type of Device: DOSE CORONARY DRUG ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 8448156
• MDR Text Key: 139745723
• Report Number: MW5085103
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2020
• Device Model Number: RONYYX20015UX
• Device Catalogue Number: RONYYX20015UX
• Device Lot Number: 0009159509
• 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): Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 71