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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 RONYX30030X
Device Problems Fracture; Activation, Positioning or SeparationProblem; Material Deformation
Event Date 09/18/2019
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, non calcified lesion exhibiting 95% stenosis located in the mid left anterior descending artery (lad). The device was inspected with no issues noted. Negative prep was performed without issue. The lesion was crossed with a non-medtronic guide wire and pre-dilated using a 2. 25 x 10 mm and 2. 5 x 20 mm balloon at 12atm for 20 seconds. 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. The stent was deployed at 14atm for 20 seconds. The stent was post-dilated using a 3. 25 x 15 mm nc balloon at 14atm for 20 seconds. It was reported that after post dilation that a minor stent fracture was observed in the mid segment of the stent which was not significant for stent overlapping. Timi 3 flow was achieved with no residual stenosis in the treated lesion. The patient was reported to be alive with no injury.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Image analysis summary: an image shows a stent in the proximal lad. A lesion is visible in the lcx. An image shows a stent in the proximal lad, there is minor stent separation visible possibly due to lesion morphology. A contrast image shows minor stent separation to the mid-section of the stent. A contrast image shows minor stent separation to the mid-section of the stent. A non-contrast image shows the deployed stent. Possible separation of the stents struts is visible. A contrast image shows minor stent separation to the mid-section of the stent. A contrast image shows minor stent separation to the mid-section of the stent. An image shows a second guide wire visible in the proximal vessel. An image shows post dilation of the stent. An image shows post dilation of the stent. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Cine review: the mid lad lesion presented as a total occlusion prior to the initial pre-dilatation of the lesion, after which the lesion exhibited no tortuosity, calcified lesion exhibiting 95% stenosis, but flow had been restored to the distal vessel. Deployment of the resolute onyx stent showed that air was present in the distal balloon, suggesting that the delivery system may not have been adequately prepped prior to delivery. But this would have had no impact on the stent fracture allegation. The deployment profile of the stent shows a tight section in the lesion where the stent does not appear to have expanded concentrically. This is most likely due to the fibrotic nature of the lesion. This restriction in the vessel was seen during the pre-dilatation activities, with the stent deployment and again during the post dilatation activities. The post dilatation activities appear to have resulted in the previously adjacent non welded sections of the sinusoidal stent being pushed apart to facilitate full apposition of the stent against the vessel wall. This is what appears to have been identified as a stent fracture. There is no evidence of stent weld or wire breakage from the images provided. Final angiographic images of the vessel confirm timi flow with no apparent restriction in flow at the site where the alleged stent fracture was identified. 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 Key9108481
Report Number9612164-2019-04044
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRONYX30030X
Device LOT Number0009524528
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 Received12/17/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/09/2019
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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