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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 RONYX35038X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myocardial Infarction (1969); Stenosis (2263); Patient Problem/Medical Problem (2688)
Event Date 02/09/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure one resolute onyx stent was implanted into the lad.Approx 8 months post index procedure, the patient suffered a late presentation anterior mi.The mi occurred in the target vessel- lad.Instant restenosis of the stent in the lad was observed.The patient was treated with pci, surgical intervention and medication.The patient recovered.The investigator reported that the event is possibly related to the device and the anti platelet medication.
 
Manufacturer Narrative
The patient was not treated with pci.The patient had a coronary angiogram.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The patient was not treated with surgical procedure.The patient was treated with pci.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 Key8403643
MDR Text Key138228613
Report Number9612164-2019-00819
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeMY
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 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/10/2019
Device Catalogue NumberRONYX35038X
Device Lot Number0008875641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2019
Initial Date FDA Received03/08/2019
Supplement Dates Manufacturer Received03/22/2019
05/09/2019
Supplement Dates FDA Received04/15/2019
05/24/2019
Date Device Manufactured11/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age66 YR
Patient Weight81
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