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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombus (2101); Injury (2348)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

Literature reference: 10.1002/ccd.28413.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to evaluate safety and efficacy of polymer-free biolimus-eluting stents (pf-bess) versus ultrathin stents in the treatment of unprotected left main (ulm) or bifurcation lesions.The study selected patients treated for ulm or bifurcation from two multicenter real life registries: rain which evaluated ultrathin stents and chance which assessed pf-bess.Patients were enrolled in both studies from january 2015 to december 2017.Resolute onyx rx coronary drug-eluting stents, along with four other non-medtronic stents were implanted in patients enrolled in the rain registry.Resolute onyx was noted to be the most exploited ultrathin stent.3,003 patients from the rain registry (treated with ultrathin stents) and 446 patients from the chance registry (treated with pf-bes) were included in the analysis with consideration only given to those with a lesion involving ulm or bif.After propensity score with matching, 562 patients in the ultrathin group and 281 in pf-bes were selected.The primary endpoint was major adverse cardiac events (mace; a composite of all-cause death, myocardial infarction, target lesion re vascularization [tlr], and stent thrombosis [st]), with target vessel revascularization (tvr) being a secondary endpoint.Clinical outcomes reported in the study population included all cause death, cardiac death, myocardial infarction, target lesion rev ascularization [tlr], and stent thrombosis.No information was available about the cause of death.After 12 (8¿20) months, similar rates of mace between pf-bes and ultrathin des were recorded, without a difference in tvr and tlr.It was stated that no significant differences in terms of primary and secondary endpoint were found between the different types of ultrathin stents.Among patients treated with 1 month of dapt in both groups, those with ultrathin stents experienced higher rates of mace related to all-cause death with higher although not significant rates of st.It was stated that the higher risk of all-cause death in patients treated with ultrathin stents may be related to diagnosis of malignancy and/or life threatening conditions requiring short dapt.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9847929
• MDR Text Key: 189582707
• Report Number: 9612164-2020-01212
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 03/18/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR