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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
Model Number RONYX35015UX
Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/12/2019
Event Type  malfunction  
Manufacturer Narrative
Additional information: the device was inspected before use with no issues reported. Device evaluation summary: the stent had moved proximally on the balloon and was not positioned on the balloon between the marker bands as per specifications. Crimp impression were visible on the exposed balloon surface. The balloon folds were expanded. Deformation was evident to the entire stent with struts raised and stretched. Deformation was evident to the distal tip. Kinks were evident to both hypotube and distal shaft. No other damage was evident to the remainder of the device. If information is provided in the future, a supplemental report will be issued.
 
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 coronary drug eluting stent. It was reported that the stent did not deploy, the stent got pushed back proximal to the balloon on the shaft of the delivery system. No patient injury was reported.
 
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 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 Key9254946
MDR Text Key174044818
Report Number9612164-2019-04543
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier00643169557079
UDI-Public00643169557079
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 01/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/19/2020
Device Model NumberRONYX35015UX
Device Catalogue NumberRONYX35015UX
Device Lot Number0009447967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/20/2018
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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