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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 RONYX27518X
Device Problems Difficult To Position; Material Deformation
Event Date 07/26/2016
Event Type  Malfunction  
Event Description

The patient had a history of hypertensive with no prior history of coronary artery disease or pci, presented in emergency room with inferiolateral stemi. Hemodynamically stable at that time. Patient received ufh and ticagrelor loading dose along with standard acute coronary syndrome treatment in the emergency room. The patient was moved to the cath lab for primary pci. Lhc was done through right radial access. The lcx was calcified and the culprit vessel. The lesion was wired and pre-dilated with the 3. 0 x 15 nc balloon. The uninflated balloon crossed the lesion without any resistance. The physician then used a resolute onyx 2. 75 x 38 mm, the physician inspected the stent before use and there was no issue. Initially little resistance was encountered while the lesion, physician then used a buddy wire. The stent was unable to cross the lesion with the help of buddy wire and so a guide liner was introduced. The stent was unable to cross the lesion. The stent was removed from the guide and physician noticed the stent struts was damaged. Patient was unstable and very restless. The guide was disengaged. Then the femoral access was taken in order get the better guide support. The physician again pre-dilated the lesion with 3. 0 x 15 nc balloon at higher pressure. Then a 2. 75 x 18 resolute onyx was used. Again it was unable cross the lesion with the help of buddy wire and guideliner. It was reported that the stent struts were damaged. Patient became unstable during the procedure and requiring intermittent cpr and intropic support. Finally timi 3 flow was achieved after ballooning, so the procedure was stopped. Patient was shifted to coronary care unit. About 30 minutes after the procedure patient had cardiac arrest and did not revived after 30 minutes of cpr. The procedural images are available in cd. Please note that this device, resolute onyx is not marketed in the united states; however, it is similar to the united states marketed product 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

Evaluation summary: the device returned with kinks on the hypotube 23cm, 31cm, and 72. 8cm distal to the strain relief. The stent was positioned on the balloon between the marker bands as per specifications. There was deformation to the 5th distal stent wrap with struts raised. The distal tip was not damaged.

 
Manufacturer Narrative

Cine image review: the procedural images confirm severe stenosis on a very acute 90 degree bend and then severe stenosis in the distal lcx. The images capture the attempted delivery of the 18mm stent and subsequent balloon inflations. After re-ballooning the mid-cx is dissected but flow is maintained. Calcium is visible in both lad and cx vessel. The cx is dilated but does not fully release with pre-dilatation. (b)(4).

 
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 Key5903035
Report Number9612164-2016-00894
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/16/2018
Device Catalogue NumberRONYX27518X
Device LOT Number0007941338
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/05/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/17/2016
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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