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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
Catalog Number RONYX20012UX
Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or SeparationProblem (2906); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 12/30/2021
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 severely calcified lesion. The device was inspected with no issues. Negative prep was performed with no issues. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device. Excessive force was not used.  it was reported that stent dislodgement occurred during delivery to the lesion. The stent was deployed at 4 atm, but the stent was not deployed properly and floated in the vessel. The dislodged stent was crushed in the profunda artery. The patient is alive with no further 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13235317
MDR Text Key283672513
Report Number9612164-2022-00166
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
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX20012UX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/12/2022 Patient Sequence Number: 1
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