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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 RONYX27522UX
Device Problems Activation, Positioning or SeparationProblem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 06/25/2021
Event Type  Injury  
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 drug eluting stent to treat a calcified lesion located in the proximal right coronary artery (rca). The device was inspected with no issues noted. The lesion was pre dilated. It was reported that stent dislodgement occurred during removal following failed delivery. It was stated that the device easily passed mid portion of rca but wouldn¿t deliver distal to the lesion. A guideliner was then used to deliver the stent. The device was pulled back and resistance was felt. It was noted that there was no stent on balloon and that the proximal edge of the stent was somewhat opened. As the guidewire was still in the patient, the physician was able to balloon with a 1. 2mm balloon at proximal part of the stent but wasn¿t able to get it fully ballooned as the balloon would not advance. An attempt to use a non-medtronic microcatheter was also performed with no success. 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12082578
MDR Text Key258851182
Report Number9612164-2021-02514
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 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX27522UX
Device Catalogue NumberRONYX27522UX
Device Lot Number0010409722
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 Received08/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/09/2020
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: 06/29/2021 Patient Sequence Number: 1
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