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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 RONYX40022X
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure one resolute onyx rx coronary drug eluting stent was used to treat a lesion. There was no damage noted to the packaging. There was no issues noted when removing the device from the hoop. The device was not inspected. Negative prep was not performed. It was reported that the stent was implanted in the patient approximately 7 weeks after the expiration date. The patient was reported to be alive with no injuries.
 
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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 Key9705280
MDR Text Key191129926
Report Number9612164-2020-00702
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 02/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2019
Device Catalogue NumberRONYX40022X
Device Lot Number0008914214
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/08/2017
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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