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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 RONYX22526JX
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 10/21/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A resolute onyx coronary drug eluting stent was used to treat a non-tortuous, moderately calcified lesion, with 90% stenosis in the distal and mid left anterior descending (lad) artery. The device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was pre-dilated three times at 20 atm with a non-medtronic nc balloon, however the lesion was still calcified. Therefore it was decided to stent the lesion using the resolute onyx device. 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. The onyx was deployed at 16 and 20 atm for 10 seconds. It was reported that the proximal section of the stent was implanted on the plaque and a slight apposition failure was observed in the proximal strut due to the effect of the calcification. Post dilation was performed to 3. 0mm or more with different size balloon. Intravascular ultrasound (ivus) confirmed that good inflation was obtained and the procedure was completed. It was also reported that stent thrombosis occurred within 24h post implantation. It was suggested that the thrombus was already present in the stent at the time of the final angio. The patient complained of chest pain 6 hours after the procedure in the hospital ward, so an emergency angio was performed and the proximal resolute onyx that was implanted was completely occluded with a thrombus. It was indicated that the thrombus may have occurred due to the stent apposition failure. The event was treated with a long inflation performed with a non-medtronic balloon. The patient is alive and no further injury was 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 Key12750320
MDR Text Key280051292
Report Number9612164-2021-04214
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX22526JX
Device Lot Number0010663535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/30/2021
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: 11/04/2021 Patient Sequence Number: 1
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