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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
Catalog Number RONYX35022X
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
Journal article: primary percutaneous coronary intervention of anomalous origin of a high take-off of right coronary artery arising from ascending aorta with percutaneous cardiopulmonary support in acute myocardial infarction authors: takuya shimizu, ken umetani, miu eguchi journal: clin case rep. Year: 2021 reference: doi. Org/10. 1002/ccr3. 4230. Date of event: date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article titled - primary percutaneous coronary intervention of anomalous origin of a high take-off of right coronary artery arising from ascending aorta with percutaneous cardiopulmonary support in acute myocardial infarction - was submitted for review. This article describes a rare case of successful percutaneous coronary interventions (pci), thrombus aspiration, and stent placement in the setting of percutaneous cardiopulmonary support (pcps) in a patient with st-elevation myocardial infarction (stemi) and anomalous origin of a very high take-off of right coronary artery (rca) arising from the ascending aorta (aao). The patient arrived to hospital in a state of cardiac arrest with no cardiac output. A non-medtronic (mdt) pcps was inserted via the right femoral artery and left femoral vein and return of spontaneous circulation (rosc) was achieved. An immediate echocardiography revealed severe hypokinesis at the left ventricular inferior regions and moderate hypokinesis at other regions with an ejection fraction of about 20%. Emergent coronary angiography (cag) was performed and revealed severe stenosis of the proximal rca with low cardiac output and low blood flow velocity in the aao. A 6fr amplatz left (al) launcher guide catheter was used to cannulate the rca. A non-mdt guidewire was passed through the stenosis, however, the launcher disengaged easily because of inadequate backup support. A non-mdt guide extension catheter (gec) was inserted to strengthen the backup of the pci system smoothly. Once positioned, the gec clearly revealed 99% stenosis of the proximal rca and massive thrombi of the distal portion of the lesion. Thrombus aspiration was done with a non-mdt device. Post thrombus aspiration with a non-mdt intravascular ultrasound (ivus) showed a large quantity of attenuated plaque at the stenotic portion, small residual thrombus at the distal portion of the lesion, and thin superficial calcification in the extensive regions but not extrinsic compression of the rca. The culprit lesion was then treated with a 3. 5 x 22 mm resolute onyx drug-eluting stent. Ivus showed a little malposition at an ecstatic portion and slight tissue protrusion into the stent, but overall there was good stent expansion and the final cag revealed good coronary blood flow and no distal embolization. Pcps, intra aortic balloon pump (iabp), and mechanical ventilation were removed on days 5, 6, and 11, post pci, respectively. Postprocedural complications were notable for difficulty walking due to deconditioning and muscle weakness, but no evidence of hypoxic brain injury was noted. The contrast-enhanced computed tomography on day 13 revealed neither neurologic damage nor systemic embolization. Ejection fraction was improved to 45%. Patient remained stable and was ultimately transferred to another hospital for rehabilitation on day 36.
 
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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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12512130
MDR Text Key272670118
Report Number9612164-2021-03650
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,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX35022X
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 Received10/13/2021
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

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