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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 RONYX30008X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Myocardial Infarction (1969)
Event Date 08/03/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During index procedure, three resolute onyx drug eluting stents were implanted; two in the cx and one in the lcma. It was reported that a grade c dissection occurred in the cx. The dissection is reported to have occurred secondary to pre-dilation and was not caused by the stents implanted. The dissection was not caused by a medtronic device. The patient suffered an mi which was reported to be related to this dissection. The investigator assessed the event as not related to the index device or anti-platelet medication. Safety assessed the event as not related to the to the device and not related to anti-platelet medication. The patient recovered.
 
Manufacturer Narrative
The patient¿s indication for index pci was an nstemi. No mi has been reported as adverse event. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The dissection is reported to have occurred due to the predilation balloon. 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 Key8188785
MDR Text Key131126688
Report Number9612164-2018-03753
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P160043
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
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/15/2020
Device Catalogue NumberRONYX30008X
Device Lot Number0009080927
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 Received01/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
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