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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 RONYX30030UX
Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Leak/Splash (1354); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Activation, Positioning or SeparationProblem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 12/22/2021
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 rx coronary drug eluting stent to treat a mildly tortuous, moderately calcified lesion in the proximal saphenous vein graft (svg). The device was inspected with no issues noted. The lesion was not pre-dilated.  the device did not pass through a previously-deployed stent.  excessive force was not used during delivery. It was reported that inflation difficulties occurred during stent deployment. It was also reported that he balloon burst at 6 atm during stent deployment at the lesion site. From the film, it was suggested the balloon did not appear to inflate more than 2 atms. It was also suggested that either the device was defective due to the lack of high pressure or it was a sharp plaque. A filter was in use to remove the stent. When attempting to remove the filter and the stent back to the femoral right side, it got stick at the sheath and could not be removed. A 7f sheath was then used in the left side to go over the horn and snare the filter, pulling everything out. No further patient injury was reported.
 
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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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13191249
MDR Text Key283397473
Report Number9612164-2022-00112
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX30030UX
Device Catalogue NumberRONYX30030UX
Device Lot Number0010834501
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2021
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: 01/07/2022 Patient Sequence Number: 1
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