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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT

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MEDTRONIC IRELAND RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number RONYX27538X
Device Problems Burst Container or Vessel (1074); Activation, Positioning or SeparationProblem (2906); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 09/23/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use a resolute onyx coronary drug eluting stent to treat a moderately calcified, moderately tortuous lesion in the mid right coronary artery (rca). There was no damage noted to the device packaging. There were issues noted when removing the device from the protective hoop. The device was inspected with no issues noted. The lesion was dilated. Resistance was not encountered while advancing the device. The device was not moved or repositioned in the lesion while inflated. Approximately three inflations were repeated as stent didn¿t deploy as expected. It was reported that after the stent was not deployed properly. The balloon was ruptured during the balloon inflation at 4 atm, leaked and was fully removed with the support of existing guide catheter and ptca wires. Another stent was deployed along the previous one to complete the procedure. The patient is alive with no injury.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12637942
MDR Text Key276578272
Report Number9612164-2021-03956
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX27538X
Device Catalogue NumberRONYX27538X
Device Lot Number0010487222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2020
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: 10/15/2021 Patient Sequence Number: 1
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