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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 RONYX22512UX
Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 12/03/2021
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 non calcified lesion in the distal right coronary artery (rca). The device was inspected with no issues noted. The device did not pass through a previously-deployed stent. Excessive force was not used during delivery. It was reported that stent dislodgement occurred during delivery to the lesion. It was stated that the stent was deployed at 8atm but at the time of inflation the stent came loose and floated downstream. A second stent was deployed to crush the dislodged stent against the arterial wall. No further patient injury is 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key13009171
MDR Text Key282260530
Report Number9612164-2021-04861
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 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX22512UX
Device Catalogue NumberRONYX22512UX
Device Lot Number0010572658
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/21/2021
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: 12/15/2021 Patient Sequence Number: 1
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