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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 RONYX40026UX
Device Problems Deflation Problem (1149); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
Event Type  malfunction  
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 mildly tortuous, non-calcified lesion exhibiting 80% stenosis in the mid left anterior descending (lad) artery. There was no damage noted to the packaging. The device was inspected with no issues noted. Negative prep-was performed. The lesion was not pre dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that balloon deflation difficulties were encountered. It was stated that the device was slow to deflate at the lesion. The deflation time was 240 seconds. Multiple negative pulls were performed. The patient was reported to be 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 Key11397983
MDR Text Key234208663
Report Number9612164-2021-00825
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX40026UX
Device Catalogue NumberRONYX40026UX
Device Lot Number0010340857
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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