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

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.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: CORONARY 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 Key: 13591169
• MDR Text Key: 290550149
• Report Number: 9612164-2022-00776
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male