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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 RONYX30026X
Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A resolute onyx device was intended to be used to treat a severely tortuous, severely calcified lesion with (b)(6) stenosis in the distal circumflex.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.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.It is reported that stent deformation occurred in vivo during positioning.The physician did not complete the procedure.No patient injury is reported.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
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.
 
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Brand Name
RESOLUTE ONYX RX
Type of Device
STENT, 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 Key7701802
MDR Text Key114713938
Report Number9612164-2018-01793
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRONYX30026X
Device Lot Number0008636149
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/21/2018
Initial Date FDA Received07/19/2018
Supplement Dates Manufacturer Received08/08/2018
09/26/2018
Supplement Dates FDA Received10/03/2018
10/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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