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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 RONYX25022X
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2016
Event Type  Malfunction  
Manufacturer Narrative

Product analysis : there were numerous kinks on the distal shaft extending approx. 3cm proximally from the proximal balloon bond. The distal shaft was kinked 11 and 11. 6cm distal to the guidewire entry port. The stent was positioned on the balloon between the marker bands as per specifications. There was deformation to the 7th distal stent wrap with struts raised. A number of the stent wraps had stent struts misaligned. There was no deformation to the distal tip. Image review: the images confirm the lesion morphology of the obtuse marginal as reported by the account. The images capture two attempts to deliver unidentified balloons to the lesion site. The images do not capture the attempted delivery of the resolute onyx stent, or the subsequent deformation and withdrawal. An unidentified balloon is inflated to treat the lesion site. (b)(4).

 
Event Description

It was reported that the physician was attempting to use a resolute onyx rx drug eluting stent to treat a severely calcified and severely tortuous mid om lesion exhibiting 95% stenosis. No issues noticed when removing the device from its packaging and no damage noted to device packaging. The device was inspected with no issues noted. Negative prep was not performed. The lesion was pre-dilated. During the procedure, the device passed through a previously deployed stent. Resistance was encountered and excessive force was used. It was reported that stent deformation occurred in vivo during positioning. The physician completed the procedure using poba. No patient injury reported for this event please note that this device resolute onyx is not marketed in the united states; however, it is similar to the united states marketed device resolute integrity. This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

 
Manufacturer Narrative

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 Key6188378
MDR Text Key62791559
Report Number9612164-2016-01331
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeGR
PMA/PMN NumberP110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/24/2018
Device Catalogue NumberRONYX25022X
Device LOT Number0007908580
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/12/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/25/2016
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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