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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
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
Event Date 07/31/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient was reported to be on dapt for stable angina. On (b)(6) 2018, three resolute onyx rx coronary drug eluting stents were implanted to treat a lesion located in the right coronary artery # 1, # 2, and # 3. It was stated that poba was performed and timi flow 3 was achieved. On (b)(6) 2019, one year on another resolute onyx stent was implanted. It was reported that on (b)(6) 2019 the patient suffered from stent thrombosis and non-fatal myocardial infarction developed. It was stated that it was probable that there was a site of poor stent expansion due to some calcification and that there was some thrombosis. The treatment had to be terminated in a slow flow state, which was considered to cause the thrombosis. The background factor was considered to be a hemodialysis (hd) patient. It was stated that an emergency pci was performed for rca # 1, # 2, and # 3 on the same day. Thrombus aspiration was performed but no stent placement. Timi flow grade 0 -> 2 was achieved. The patient was reported to have recovered from non-fatal myocardial infarction. The next day cardiac dysfunction occurred and an emergency pci was performed on the rca # 2. Thrombus aspiration was performed and poba was performed. No stent implantation was performed. Pcps was used. Timi flow grade 0 -> 0 was achieved. Two days later the patient recovered from cardiac dysfunction and stent thrombosis.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11513324
MDR Text Key240572955
Report Number9612164-2021-01027
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
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,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received04/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/18/2021 Patient Sequence Number: 1
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