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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
Lot Number UNKNOWN
Device Problem Migration or Expulsion of Device
Event Date 06/10/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Two resolute onyx drug eluting stents were used in a complicated procedure in a patient that had previous in stent restenosis and multiple stent graphs from previous heart surgery. It is reported that both of the resolute onyx stents were deployed and the second one pulled back out of the proximal left main and protruded 1-2mm outside the vessel in the aorta after been deployed. The case was successful and the physician was very satisfied with the performance of the resolute onyx des. The patient is alive with no injury. The physician stated that they had no issue or complaint in regards to the stent or its performance in that or any case, but only had a question of dapt/anticoagulation therapy in a case where 1-2 mm of a left main stent was still in the aorta after deployment.

 
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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 Key8801640
Report Number9612164-2019-02927
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberUNKNOWN
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 Received06/19/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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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