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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 RONYX35018UX
Device Problems Stent (515); Mechanical Problem (1384); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

A resolute onyx drug eluting stent was intended to be used during a procedure. The intended lesion was located in the cx artery. There was abnormalities reported in relation to anatomy- an anomalous lcx. There was no damage noted to packaging. There were no issues removing the device from the hoop. 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. It is reported that stent deformation occurred in-vivo during positioning/advancement. The stent could not cross the lesion. When the stent was removed from the patient, it was noted that a stent strut in the middle of the stent was lifted up. The procedure was completed using another 3. 5x18 onyx. No patient injury is reported.

 
Manufacturer Narrative

Additional information received reported that the lesion was in the anomalous left circumflex (originating off of the rca), with moderate tortuosity. The lesion exhibited 90%. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Product analysis summary: there was a kink on the catheter 12. 8cm distal to the strain relief. The stent was positioned on the balloon between the marker bands as per specifications. Deformation was evident to the 7th and 8th distal stent wraps with struts raised. Deformation was evident to the distal tip. The inner lumen patency was verified with a 0. 015 inch mandrel. 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 Key7697466
MDR Text Key114679622
Report Number9612164-2018-01780
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/22/2020
Device Catalogue NumberRONYX35018UX
Device LOT Number0009006916
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/22/2018
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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