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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 RONYX27512X
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
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 severely tortuous, severely calcified lesion with chronic total occlusion (cto) in the ostium of the right coronary artery (rca) and the circumflex (cx) artery. The device was inspected with no issues noted. Negative prep was performed with no issues noted. The lesion was pre-dilated.  the device did not pass through a previously-deployed stent. Resistance was encountered when advancing the device. Excessive force was used during delivery.  it was reported that stent deformation occurred in vivo during positioning. The procedure was completed using a non medtronic stent. 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13051264
MDR Text Key283513390
Report Number9612164-2021-04944
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/08/2022
Device Catalogue NumberRONYX27512X
Device Lot Number0010168908
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2020
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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