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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 RONYX22526UX
Device Problems Activation, Positioning or SeparationProblem (2906); Device Damaged by Another Device (2915)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 05/18/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure, attempt was made to implant one resolute onyx rx coronary drug eluting stent to treat a mildly tortuous and moderately calcified lesion in the mid cx artery with 95% stenosis. The device was inspected with no issues noted. The device was prepped per ifu with no issues noted. Negative prep was performed with no issues noted. It was noted that the vessel was an anomalous circumflex which arose from the aorta. The lesion was predilated. The device did pass through a previously resolute onyx des deployed stent. Resistance was encountered when advancing the device. Excessive force was used during delivery. It was reported that a stent dislodgement occurred during delivery to/at lesion. The dislodged stent was dilated against the ostial/proximal wall of the artery with a coronary balloon. It was informed that the stent dislodgement occurred due to the struts becoming entangled with the struts of a previously deployed resolute onyx des stent. Once entangled, the removal of the delivery system resulted in the stent remaining at the ostial portion of the anomalous circumflex. The physician believes that the previously deployed resolute onyx des may not have been optimally opposed to the arterial wall and the subsequently delivered stent caught on a strut. The entire segment dilated with a balloon after becoming entangled with the dislodged resolute onyx des, and has remained implanted. The patient is alive with no further injury 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 Key11997709
MDR Text Key256155585
Report Number9612164-2021-02300
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 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/03/2022
Device Catalogue NumberRONYX22526UX
Device Lot Number0010265334
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/03/2020
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: 06/15/2021 Patient Sequence Number: 1
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