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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 RONYX30018UX
Device Problem Fracture
Event Date 01/29/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a severely tortuous and calcified lesion exhibiting 95% stenosis located in the distal rca. The device was inspected with no issues. Negative prep was performed with no issues. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device necessitating force. It was reported that a fracture occurred in the catheter during delivery through the vessel, however the fracture did not occur all the way through. There is no portion of the device remaining in the patient. It was indicated that there was also a kink in the device. The patient is reported to be alive with no injury.

 
Manufacturer Narrative

Additional information: it was reported that a fracture occurred in the catheter during delivery through the vessel, however the fracture did not occur all the way through, it was thought that the coating was holding it together. It is indicated that the detachment occurred as the physician removed the device from the touhy but enough of the hypotube was sticking out of the touhy for the physician to pull it with their fingers. Product analysis summary: the device returned with a detachment on the hypotube 79. 3cm distal to the strain relief. A kink was evident on the hypotube 3. 6cm proximal to the detachment site. The hypotube material was oval and jagged on both sides of the detachment site. No other damage evident to the remainder of the device. 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 Key8292372
Report Number9612164-2019-00376
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRONYX30018UX
Device LOT Number0009184062
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/12/2018
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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