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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT

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MEDTRONIC IRELAND RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Insufficient Information (4580)
Event Date 09/09/2020
Event Type  Injury  
Event Description
An article was submitted for review titled: percutaneous coronary intervention for delayed coronary obstruction due to endothelialization of self-expandable transcatheter heart valve: a case report. The case report is of a patient who underwent transcatheter aortic valve implantation with a self-expandable valve, without any complications. The patient was admitted to hospital eight months later with effort angina. Electrocardiography showed new st-segment depression in v5¿6 leads. The tte showed hypokinesis in the anterior segment and eoa of 1. 56 cm2. Laboratory test results were within normal value, except for high-sensitivity troponin i levels. Adenosine stress myocardial perfusion scintigraphy performed to identify ischaemic area showed myocardial ischaemia in the anterior region. Computed tomography revealed that the thv frame was covered with a low-density mass between the leaflet and stj, which occluded the left coronary sinus (lcs). The transoesophageal echocardiogram (toe) showed a doppler signal flowing from the ncs to the lcs was detected through a gap between aortic wall and the thv. The roundabout route was also confirmed using the corresponding ct image. A coronary guidewire was inserted through the roundabout route from the ncs into the lcs. Using a dual-lumen microcatheter, another coronary guidewire was advanced into the distal left anterior descending artery. Following balloon angioplasty, a 4. 00 mm x 15 mm resolute onyx drug eluting stent was deployed into the roundabout route. The intravascular ultrasound (ivus) showed under-expansion of the stent, despite post-dilatation with a 4. 0-mm non-compliant balloon. Another 4. 00 mm x 15 mm resolute onyx drug eluting stent was implanted into the first stent, which improved stent expansion. Final coronary angiography showed a roundabout route and improved flow to the left coronary artery. After the procedure, the patient¿s symptom improved. At the 4-month follow-up, the patient had remained asymptomatic.
 
Manufacturer Narrative
Journal article: percutaneous coronary intervention for delayed coronary obstruction due to endothelialization of self-expandable transcatheter heart valve: a case report. Year: 2020 ref: doi:10. 1093/ehjcr/ytaa288 b3: date of publication. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13511908
MDR Text Key289184845
Report Number9612164-2022-00571
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
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
Date Manufacturer Received03/14/2022
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: 02/11/2022 Patient Sequence Number: 1
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