MAUDE Adverse Event Report: MEDTRONIC RESOLUTE ONYX STENT

Lot Number (10)0010391945

Device Problems Dislodged (1179); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2021

Event Type  Injury  

Event Description

During pci, after balloon inflation, onyx stent inserted into left recovery artery, stent dislodged from balloon and was unable to be retrieved by physician.

• Brand Name: RESOLUTE ONYX STENT
• Type of Device: STENT
• Manufacturer (Section D): MEDTRONIC ; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11496229
• MDR Text Key: 240113721
• Report Number: 11496229
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: (10)0010391945
• 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: 03/09/2021
• Distributor Facility Aware Date: 03/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• 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
• Patient Age: 86 YR
• Patient Weight: 73