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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 RONYX35030X
Device Problems Fracture (1260); Activation, Positioning or SeparationProblem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A resolute onyx 3. 50x30mm was intended to treat a mildly tortuous and mildly calcified lesion in the proximal lad. It was reported that there was no damage noted to the packaging and no issues were identified when removing the device from the hoop. The device was inspected with no issues noted. The device was not kinked and re-straightened during the use. It was reported that the lesion was pre-dilated. The resolute onyx device did not pass through a previously deployed stent, resistance was not encountered when advancing the device and no excessive force was used. It was reported that the stent was fractured while pulling back the balloon after the inflation was complete. No attempts were made to remove the resolute onyx stent as it was already inflated. 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 Key12150048
MDR Text Key261003574
Report Number9612164-2021-02696
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX35030X
Device Lot Number0010436941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2020
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: 07/12/2021 Patient Sequence Number: 1
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