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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Vascular Dissection (3160); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)
Event Date 04/15/2021
Event Type  Injury  
Event Description
A journal article was submitted for review titled: elastic stent recoil in coronary total occlusions: comparison of durable-polymer zotarolimus eluting stent and ultrathin strut bioabsorbable-polymer sirolimus eluting stent. The aim of the article was to compare stent recoil between zotarolimus-eluting stents (zes) and sirolimus-eluting stents (ses). Between january 2017 and november 2019 123 patients with cto undergoing pci were evaluated. 128 lesions were treated zes (n
=
67) and ses (n
=
61). The patients being treated with the zes stent received resolute onyx drug eluting stents and those receiving ses stents were treated with a non medtronic stent. The lesions treated had chronic total occlusions (ctos) and included moderately and severely calcified lesions with tortuosity in the right coronary artery, left coronary artery, circumflex coronary artery and intermediate branch. Stents were post dilated using nc balloons. 32% of the stents was expanded beyond nominal size, but none of them was overexpanded by >20% of the nominal size. Complications that occurred during the zes procedures included: perforation, acute thrombosis, pericardiocentesis and dissection. Stent recoil occurred in both groups but was more frequently observed in the ses group. In the case of stent overexpansion, the resolute onyx stent also showed a lower increase in struts crown angle deformation compared to the ses stent.
 
Manufacturer Narrative
Title: elastic stent recoil in coronary total occlusions: comparison of durable-polymer zotarolimus eluting stent and ultrathinstrut bioabsorbable-polymer sirolimus eluting stent year: 2021 reference: doi: 10. 1002/ccd. 29739. 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 Key13591169
MDR Text Key290550149
Report Number9612164-2022-00776
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeNL
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
Report Date 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received02/09/2022
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

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