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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX

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MEDTRONIC IRELAND RESOLUTE ONYX RX Back to Search Results
Catalog Number RONYX20022JX
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 10/17/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion exhibiting 90% stenosis located in the circumflex (cx) artery.The device was inspected and negative prep performed without issues.The device was not kinked and re-straightened during the procedure.The lesion was pre-dilated using a non-medtronic device at 12atm for 15 seconds.After pre-dilation it was judged that a stent was able to be implanted.The device passed through a previously deployed non medtronic stent which was implanted two weeks previous.Resistance was not encountered when advancing the device.It was reported that the resolute onyx stent became caught in the previously implanted stent, and upon attempted removal stent dislodgement and detachment occurred.There were removal difficulties noted.The dislodged/detached portion of the device was removed successfully using a snare.The patient was reported to be alive with no further injury.
 
Manufacturer Narrative
It was reported that a full detachment of the device occurred.Previously reported implant date is not applicable as the stent was not implanted.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
RESOLUTE ONYX RX
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9237283
MDR Text Key164270724
Report Number9612164-2019-04505
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/10/2021
Device Catalogue NumberRONYX20022JX
Device Lot Number0009821032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/17/2019
Initial Date FDA Received10/25/2019
Supplement Dates Manufacturer Received10/29/2019
Supplement Dates FDA Received11/12/2019
Date Device Manufactured07/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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