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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 RONYX35018UX
Device Problems Calcified (1077); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the procedure, an attempt was made to use one resolute onyx drug eluting stent to treat a moderately tortuous and severely calcified lesion located in the mid right coronary artery, exhibiting 80% stenosis. There were no abnormalities reported in relation to anatomy. There was no damage noted to packaging. There were no issues noted when removing the device from the hoop. The device was inspected with no issues identified. Negative prep was not performed. The lesion was pre-dilated. The device did not pass through a previously-deployed stent. Resistance was encountered when advancing the device. Excessive force was not used during delivery. It was reported that the stent initially did not cross the lesion and on removal from the patient, the stent was partially crushed. The stent remained on the balloon but was severely deformed on the delivery system. The procedure was completed using a medtronic stentsuccessfully. Patient status post-procedure is alive with no injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis summary: there was a kink on the hypotube 12. 5cm distal to the strain relief. The stent had moved distally on the balloon and was not positioned on the balloon between the marker bands as per specifications. Deformation was evident to the distal stent wraps with struts raised and bunched. No deformation was evident to the distal tip. The inner lumen patency was verified with a 0. 015 inch mandrel. 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 Key7693280
MDR Text Key114676863
Report Number9612164-2018-01772
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 10/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2019
Device Model NumberRONYX35018UX
Device Lot Number0008918282
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2017
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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