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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 RONYX30026UX
Device Problems Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Material Deformation
Event Date 10/06/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Index procedure was prompted by stemi. During the procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous and moderately calcified lesion located in the proximal- mid lad exhibiting 60-70% plus stenosis. The device was inspected with no issues noted. Negative prep was not performed. The lesion was predilated using a medtronic euphora balloon. 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 was reported that when the stent was in the patient it was realised that it was too long for the lesion and was almost covering the lm bifurcation. It was decided not to deploy the stent so as not to compromise the lm/ cx ostium. No attempts were made to deploy the stent. An attempt was made to remove the stent however it would not go back into the guide catheter. The guide catheter, wire and stent were repositioned and there appeared to be a partial flaring of the stent. After multiple attempts it was decided to remove all devices in order to remove the stent out through the sheath however stent would not get into the sheath and eventually the stent was left in the radial artery having dislodged. The lesion was treated with another resolute onyx des successfully. Angiograph showed that the dislodged stent was in the side branch of the ulnar. It was agreed to do a cut down of the left ulnar artery and remove the stent on the same day. The patient did well and was discharged four days post procedure.

 
Manufacturer Narrative

Product analysis summary: stent returned dislodged from delivery system. The delivery system did not return for analysis. Deformation was evident to all stent wraps with struts appearing bunched and overlapping. The luer did not return for analysis. Lot confirmation is based on the stent matching the failure mode it was reported for. If information is provided in the future, a supplemental report will be issued.

 
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 Key7964632
Report Number9612164-2018-02739
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/20/2020
Device Catalogue NumberRONYX30026UX
Device LOT Number0009042375
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/21/2018
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: 10/15/2018 Patient Sequence Number: 1
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