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U.S. Department of Health and Human Services

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

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MEDTRONIC RESOLUTE ONYX DRUG ELUTING STENT 3.0X15 Back to Search Results
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.
 
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Brand NameRESOLUTE ONYX DRUG ELUTING STENT 3.0X15
Type of DeviceDRUG ELUTING STENT
Manufacturer (Section D)
MEDTRONIC
MDR Report Key9636611
MDR Text Key177032598
Report Number9636611
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0009186613
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/15/2020
Event Location Hospital
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/28/2020 Patient Sequence Number: 1
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