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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 RONYX50012UX
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
This stent was deployed at 12 atm in the patient's right coronary artery. Stent embolized onto guide catheter. Guide retracted and stent remained in right subclavian. Stent retrieved by snare and removed from body intact. Stent was snared and pulled back into guide. Guide was removed with stent. No patient injury.
 
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Brand NameRESOLUTE ONYX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC, INC.
7611 northland dr.
minneapolis MN 55428
MDR Report Key7164202
MDR Text Key96371281
Report Number7164202
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
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX50012UX
Device Catalogue Number(240)RONYX50012UX
Device Lot Number(10)0008735235
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2017
Event Location Hospital
Date Report to Manufacturer12/20/2017
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

Patient Treatment Data
Date Received: 01/04/2018 Patient Sequence Number: 1
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