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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING

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MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RONYX35022X
Device Problems Activation, Positioning or SeparationProblem (2906); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A resolute onyx des was used during a procedure to treat a lesion in the mid right coronary artery (rca). There was no damage noted to the packaging. There was no damage noted when removing the device from the hoop. The device was inspected with no issues. Negative prep was performed. Resistance was not encountered. Excessive force was not used. It was reported that the stent was unable to deploy. The patient is alive with no injury.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10580080
MDR Text Key208375765
Report Number9612164-2020-03609
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/02/2022
Device Catalogue NumberRONYX35022X
Device Lot Number0010201758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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