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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 RONYX25038X
Device Problems Fracture; Inflation Problem; Device Dislodged or Dislocated; Material Deformation
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

During a procedure a resolute onyx rx coronary drug-eluting stent was used to treat a moderately tortuous, moderately calcified lesion located in the proximal diagonal branch. There were issues noted when removing the device from the packaging. It was reported that there was a w like tear shape noted on the stent. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used during delivery. The device was not kinked and restraightened during use. It was reported that stent deformation occurred in vivo during positioning and the device detached, cracked or fractured at the balloon during delivery through the vessel. Upon inflating the stent balloon to 6 atm at the lesion site, high resistance was noted and no further increase in pressure could be attained. According to the angiograph, the stent was observed to be shrunk and crimped and completely degloved from the shaft to the proximal part of the artery. The shaft with the balloon was retrieved however the stent could not be retrieved and remains under expanded in the proximal part of the diagonal branch. An attempt was made to remove by partial crushing of the stent followed by wiring and snaring with distal balloon inflation. The procedure was completed using the same size and model of device. The patient was reported to be alive with no injury.

 
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Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
 
091708734
MDR Report Key9646219
Report Number9612164-2020-00476
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRONYX25038X
Device LOT Number0009410610
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 Manufactured10/31/2018
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: 01/30/2020 Patient Sequence Number: 1
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