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U.S. Department of Health and Human Services

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

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MEDTRONIC PERFUSION SYSTEMS RESOLUTE ONYX CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number RONYX22538UX
Device Problems Activation, Positioning or SeparationProblem (2906); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2020
Event Type  malfunction  
Event Description
Elderly male with history of chronic heart failure, coronary artery disease, diabetes, and hypertension. Having a percutaneous transluminal coronary angioplasty. After rotoblade in circ, stent inserted and stuck. It did not deploy. The stent delivery system was removed, and the stent was not on the balloon. The stent was lodged and traveled to left anterior descending. A snare was used to retrieve the stent. Original procedure was not completed, echo was done. Patient discharged 2 days later without known injury.
 
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Brand NameRESOLUTE ONYX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr
minneapolis MN 55428
MDR Report Key10476240
MDR Text Key205126489
Report Number10476240
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX22538UX
Device Catalogue NumberRONYX22538UX
Device Lot Number0010173383
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/20/2020
Event Location Hospital
Date Report to Manufacturer09/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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