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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 RONYX27526X
Device Problems Fracture; Material Deformation
Event Date 09/27/2019
Event Type  Injury  
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 90% stenosis located in the proximal left anterior descending artery (lad). The device was inspected with no issues noted. Negative prep was performed with no issues noted. The device was not kinked and re-straightened during use. The lesion was pre-dilated. 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 of the device. It was reported that stent fracture/deformation occurred after post-dilation of the device. It was also reported that a stent thrombosis occurred during the procedure and was treated using a 2. 75 x 23 mm non-medtronic stent. The patient was reported to be alive with no further injury.

 
Manufacturer Narrative

Additional information: the lesion was crossed with a non medtronic wire and pre-dilated with a 2. 0 x 15mm sc balloon at 12 atm for 20 seconds. The resolute onyx des was deployed at 14 atm for 20 seconds. Post dilation performed using a 2. 75 x 12mm nc balloon at 14 atm for 20 seconds. No issue was reported for the delivery system. Stent thrombosis was noted right after the procedure within an hour. The patient was on dapt at the time of the event. Image analysis review: an image provided shows a contrast image of the lad with a lesion visible in the proximal region. The lesion is pre-dilated. A stent is delivered to the lesion. The balloon is inflated, and the stent is deployed. A contrast image showing the treated lad. The lesion is post dilated. A contrast image following post dilation showing narrowing of the contrast path in the proximal lad. An image shows what appears to be possible separation of the stent struts most likely due to lesion morphology. An image shows the deployed stent; the possible stent separation is not visible from this angle. An image shows the deployed stent, with possible stent separation visible. A contrast image shows a section where the contrast flow appears lighter, indicating possible thrombus. A stent is delivered inside the previously deployed stent. A contrast image shows the path of contrast has been restored to the lad. A lesion is visible in the proximal lcx. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Image analysis summary: the stent thrombus (st) has been confirmed and this thrombus is evident from the occlusion at the proximal end of the stent in the proximal lad. This is the same area where the original deployed profile of the stent was impacted by restriction within the vessel. The stent could not be concentrically deployed across the lesion due to the vessel morphology. This restriction most likely caused turbulence in flow within the proximal stent resulting in the occurrence of a thrombus. This is not an identified stent issue. The root cause of the alleged stent fracture, which appears more likely to be stent wire misalignment, was due to the vessel morphology. This stent wire misalignment contributed to the stent thrombus. 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 Key9165961
Report Number9612164-2019-04272
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRONYX27526X
Device LOT Number0009524526
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 Received01/20/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/10/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/08/2019 Patient Sequence Number: 1
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