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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 RONYX35026X
Device Problem Device Expiration Issue
Event Date 06/20/2017
Event Type  Malfunction  
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A resolute onyx drug eluting stent was being used. There was no damage noted to packaging and no issues noted when removing the device from the hoop. The device was inspected with no issues noted. Negative prep was performed. The lesion was not pre-dilated. The device did not pass through a previously deployed stent and no resistance was encountered. No excessive force was used. It is reported that the device was 3 days past its expiration date when it was implanted. There is no patient injury.

 
Manufacturer Narrative

Additional information: there was no problem with the product and the patient did not require any additional treatment. The device is a consignment product. Medtronic are responsible for monitoring the product. It is not known where the breakdown in the process occurred. The implant date has been confirmed as the (b)(6). If information is provided in the future, a supplemental report will be issued.

 
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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 Key6753238
Report Number9612164-2017-00966
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/02/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/17/2017
Device Catalogue NumberRONYX35026X
Device LOT Number0007616721
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 Received08/02/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/18/2015
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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