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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. RESOLUTE ONYX CORONARY DRUG-ELUTING STENT

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MEDTRONIC, INC. RESOLUTE ONYX CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number RONYX35012UX
Device Problem Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 01/29/2021
Event Type  malfunction  
Event Description
A pt2 coronary guidewire was advanced into the vessel and across the lesion. A 3. 0 x 8 mm emerge balloon was advanced and used for predilatation. We then advanced a 3. 5 x 12 mm resolute onyx drug-eluting stent. On deployment the stent balloon ruptured at approximately 2 to 3 atm which flared the proximal and distal stent edge but did not fully deployed the stent.
 
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Brand NameRESOLUTE ONYX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key11347901
MDR Text Key232541066
Report Number11347901
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
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX35012UX
Device Catalogue NumberRONYX35012UX
Device Lot Number0010339532
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2021
Event Location No Information
Date Report to Manufacturer02/19/2021
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?
Type of Device Usage Unkown

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