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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 RONYX30034UX
Device Problems Inadequacy of Device Shape and/or Size; Material Deformation
Event Date 04/12/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a non tortuous, moderately calcified lesion with 70% stenosis in the proximal left anterior descending (lad) artery. The device was inspected with no issues. Negative prep was performed with no issue noted. The lesion was predilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It is reported that stent deformation occurred in vivo during positioning/advancement. It is stated that the physician put the stent in and realised it was a little short and when removing the device a strut was noted to be lifted on one end. No patient injury is reported.

 
Manufacturer Narrative

Add info: the stent was not shorter than indicated on packaging. The 34mm resolute onyx stent was chosen, but a 38mm stent was required. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Product analysis summary: the stent was positioned between the markerbands but not meeting specifications due to deformation of the proximal wraps. Deformation was evident from the 29th to 34th distal stent wraps with struts raised, bunched, and overlapping. No deformation was evident to the distal tip. The inner lumen patency could not be verified with a 0. 015 inch mandrel, most likely due to hardened blood in the guidewire lumen. 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 Key8513209
Report Number9612164-2019-01320
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/09/2020
Device Catalogue NumberRONYX30034UX
Device LOT Number0009076599
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/10/2018
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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