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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
Device Problem Inadequacy of Device Shape and/or Size
Event Date 03/15/2018
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

During the procedure, one resolute onyx rx drug eluting stent was used to treat a to treat a lesion. There were no abnormalities reported in relation to anatomy. There was no damage noted to packaging. There were no issues noted when removing the device from the hoop. The device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was pre-dilated. There was no resistance noted when advancing the device to the lesion. The stent was deployed at 12 atm. It was not post-dilated. It was reported that the patient had stent thrombosis 48 hours after stent implantation. The patient was on dapt. The patient was brought to the lab to treat the stent thrombosis. It was reported that the onyx was undersized. The cine images of the implant procedure were reviewed by the account. It was reported that there was an edge dissection proximal to the stent. Another medtronic stent was placed to treat the dissection. The dissection had been missed on the last pictures in the first case. The patient needed ecmo for extra support. It was reported that the patient died during the second procedure to open the thrombosis. The ecmo device was not inserted correctly causing the patient to bleed and unrecover. The patient expired.

 
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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 Key7432079
Report Number9612164-2018-00796
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received03/18/2018
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

Patient TREATMENT DATA
Date Received: 04/16/2018 Patient Sequence Number: 1
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