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 Stroke/CVA (1770); Myocardial Infarction (1969); Vascular Dissection (3160); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

Title: intravascular ultrasound guided intervention in calcified coronary lesions showed good clinical outcomes during one year follow-up year: 2023 reference: doi:10.3390/jcm12124073 a2: average age a3: majority gender b3: date of publication.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted for review titled; intravascular ultrasound guided intervention in calcified coronary lesions showed good clinical outcomes during one year follow-up.The aim of this study was to evaluate the clinical efficacy of intravascular ultrasound (ivus) guided percutaneous coronary intervention (pci) in calcified coronary lesions, and the clinical outcomes after at least one year of follow-up, using the capiro (calcified plaque in patients receiving resolute onyx) study.Capiro is a prospective, multi-center study.From august 2018 to december 2021, this study evaluated 243 patients (with 265 lesions) who were followed up for more than one year.The patient population was separated into two groups based on the degree of calcification detected by ivus.Based on coronary calcification by ivus analysis, the patient population was categorized into two groups; group i: non/mild calcification (151 patients, 171 lesions), and group ii: moderate/severe calcification categorized as lesions with a maximum calcium arc >180° and a calcium length of more than 5 mm (92 patients, 94 lesions).If a patient has numerous lesions, classification is based on the lesion with the most significant calcification.One-to-one propensity score matching (psm) was used to match the baseline characteristics.All patients were administered a loading dose of antiplatelet medications before the procedure.Vascular access was obtained via the radial or femoral artery.Non-medtronic (mdt) ivus systems were utilized.Lesions with total occlusion or severe stenosis that the ivus catheter may not be able to cross were pre-dilated with a compliant balloon.Utilization of a non-compliant balloon or adjunctive lesion preparation was left to the clinician¿s discretion.Every patient received the resolute onyx zotarolimus-eluting stent.After stent implantation, ivus images were acquired to evaluate stent deployment results (minimum stent area (msa), expansion rate, apposition) and acute complications (dissection, thrombus, hematoma, and tissue protrusion).Using an additional non-compliant balloon for post-dilation was determined by clinical circumstances and the clinician¿s discretion.The final ivus image was recorded.After pci, patients were treated with guideline-directed medical therapy.The primary clinical outcome was major adverse cardiac events (mace), which included cardiac death, myocardial infarction (mi) of the target vessel, and target lesion revascularization (tlr).Secondary endpoints include patient-oriented composite endpoint (all-cause death, mi, and any revascularization), the individual components of mace, all-cause death, stroke, target vessel revascularization (tvr), other vessel revascularization (ovr), chronic heart failure (chf), and stent thrombosis.Before the psm, mace was 1.99% in group i, which was not significantly different from group ii with 1.09%.Secondary outcomes, including patient-oriented composite endpoint, all-cause mortality, or components of mace, tvr, stroke, and stent thrombosis, were comparable between the two groups.After the psm, the mace rates in group i were 0%, comparable with 1.41% in group ii.The secondary endpoints remained not significantly different between the two groups.There were no episodes of stent thrombosis.Malapposition, tissue protrusion and stent edge dissection was seen in both groups post pci ivus.

Manufacturer Narrative

Additional information: annex d code.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 18449586
• MDR Text Key: 332166358
• Report Number: 9612164-2024-00087
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• 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?: No
• Date Manufacturer Received: 01/17/2024
• 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: 66 YR
• Patient Sex: Male