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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 RONYX45026X
Device Problems Activation, Positioning or SeparationProblem (2906); Device Damaged by Another Device (2915); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2021
Event Type  malfunction  
Event Description
It was attempted to use a resolute onyx coronary drug eluting stent to treat a non calcified, non torturous lesion in the proximal left anterior descending (lad) artery.  abnormalities were reported in relation to anatomy as a large clot in the lad was noted. The device was inspected with no issues. Negative prep was performed with no issues. The lesion was 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 stent deformation occurred in vivo post deployment. It was reported that the post dilation nc balloon caught the front end of the stent as it was not apposed to the vessel. It was stated that there was resistance expanding the front end of the stent despite multiple inflations at high pressure. The patient is alive with no injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key12796025
MDR Text Key284994004
Report Number9612164-2021-04348
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX45026X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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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