MAUDE Adverse Event Report: MEDTRONIC RESOLUTE ONYX DRUG ELUTING STENT 3.0X15

Lot Number 0009186613

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/15/2020

Event Type  Injury  

Event Description

During pci of rca stent dislodged from balloon, carotid image's taken.Surgeon consulted, decision to take pt to operating room for carotid exploration.No stent found in carotid.Stent found later in kidney where it remains.

• Brand Name: RESOLUTE ONYX DRUG ELUTING STENT 3.0X15
• Type of Device: DRUG ELUTING STENT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 9636611
• MDR Text Key: 177032598
• Report Number: 9636611
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0009186613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2020
• Event Location: Hospital
• 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: 64 YR
• Patient Weight: 114