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

Model Number RONYX35012UX

Device Problem Premature Separation (4045)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/17/2020

Event Type  Injury  

Event Description

Stent came off the delivery system balloon without deployment; unable to snare and remove therefore stent was deployed in body.Fda safety report id # (b)(4).

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; minnesapolis MN 55432
• MDR Report Key: 11055684
• MDR Text Key: 223441851
• Report Number: MW5098479
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: RONYX35012UX
• Device Lot Number: 0010315260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 32