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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING

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MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RONYX35038X
Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problems Perforation (2001); Injury (2348); Insufficient Information (4580)
Event Date 10/10/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

One resolute onyx coronary drug eluting stent was attempted to be used to treat a moderately tortuous, severely calcified lesion with 80% stenosis in the mid circumflex (cx) artery. The device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was not pre-dilated. The device did not pass through a previously deployed stent. Excessive force was used during delivery. The device was not kinked and re-straightened during use. It was reported that a detachment occurred at the balloon during delivery through the vessel, resulting in vessel perforation. The detached portion was then secured by a stent graft and remains in the patient. No further patient injury reported.

 
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Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10725116
MDR Text Key212688951
Report Number9612164-2020-04065
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeEG
PMA/PMN NumberP160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/25/2021
Device Catalogue NumberRONYX35038X
Device LOT Number0009763147
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 Received01/04/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/26/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/23/2020 Patient Sequence Number: 1
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