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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 RONYX27512X
Device Problems Migration or Expulsion of Device ; Device Damaged by Another Device; Material Deformation
Event Date 03/01/2019
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, moderately calcified lesion exhibiting 50% stenosis in the proximal obtuse marginal (om). The device was inspected with no issues. Negative prep was not performed. The lesion was pre-dilated. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. Excessive force was not used during delivery. It was reported that following implantation of the resolute onyx stent at 14 atm, the position of the non-medtronic guide wire was lost. The physician stated that the felt the stent was fully opposed after expanding at 14 atm. After re-entering the wire into the vessel, the wire passed behind some struts of the stent, between the vessel wall and the stent. The wire tip became bent into a hook shape in the distal vessel. Balloon dilatations were then initiated using non-medtronic balloons at 16 atm to avoid malposition. As the wire was withdrawn from the vessel, it caught on the stent struts and completely pulled the stent out of the vessel. It was reported that the stent was retrieved back to the arm where it was snared and withdrawn through the sheath. It was reported that another onyx stent was used to successfully complete the procedure. No other patient injury reported. It is reported that this event was operator related and that the device was not at fault.

 
Manufacturer Narrative

It is also indicated that stent deformation occurred. 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 Key8393553
Report Number9612164-2019-00784
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRONYX27512X
Device LOT Number0009399633
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 Received03/01/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/26/2018
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: 03/06/2019 Patient Sequence Number: 1
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