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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 RONYX20015UX
Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure a resolute onyx rx coronary drug-eluting stent was used to treat a moderately tortuous, moderately calcified lesion. There were no issues removing the device from the packaging. The device was inspected with no issues noted. 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 and excessive force was not used. It was reported that the stent was unable to be delivered to the lesion with it being removed and attempted multiple times, it was inspected again after removal before each attempt. It was noted that the stent was not able to be delivered to the lesion due to difficult anatomy. On the final attempt the stent did cross the lesion and the balloon was inflated to deploy the stent. There were no inflation difficulties. It was reported that upon its removal the stent was still on the balloon and was noted to be severely deformed. It is stated that it was thought the tuohy adapter was too tight and the stent 'accordianed' there. It is also stated that it was thought not to be the stent's fault.
 
Manufacturer Narrative
Product analysis summary: the device returned with a non-medtronic stop-cock attached to the luer. The stent was not positioned on the balloon between the marker bands. It was severely bunched and deformed, and was located over the proximal marker-band. Stent measurements could not be recorded due to the nature of deformation. Balloon folds were expanded with contrast visible in between balloon folds. A kink was evident to the distal shaft, with the underlying inner member and support wire also kinked. Deformation was evident to the distal tip. The inner lumen patency was verified with a 0. 015 inch mandrel. No other damage evident to the remainder of the device. 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 Key9609680
MDR Text Key186019225
Report Number9612164-2020-00344
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier00643169556645
UDI-Public00643169556645
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
Report Date 03/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/15/2021
Device Model NumberRONYX20015UX
Device Catalogue NumberRONYX20015UX
Device Lot Number0009877494
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2019
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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