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 Angina (1710); Stroke/CVA (1770); Myocardial Infarction (1969); Insufficient Information (4580)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

Title: fractional flow reserve¿guided pci or coronary bypass surgery for 3-vessel coronary artery disease: 3-year follow-up of the fame 3 trial year: 2023 reference: doi: 10.1161/circulationaha.123.065770 a2: average age a3: majority gender a5b: majority race b3: date of publication deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.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 'fractional flow reserve-guided pci or coronary bypass surgery for 3-vessel coronary artery disease: 3-year follow-up of the fame 3 trial'.Fame 3 (fractional flow reserve versus angiography for multivessel evaluation) is an investigator-initiated, multi-center, international, randomized trial involving patients with 3-vessel coronary artery disease (cad), not involving the left main coronary artery, in 48 centers worldwide.The aim of this study was to present the pre-specified key secondary end point of the fame 3 trial (3-year incidence of the composite of death, myocardial infarction [mi], or stroke) after coronary artery bypass grafting (cabg), compared with fractional flow reserve (ffr) guided percutaneous coronary intervention (pci) using current generation drug eluting stents (des).Patients were randomly assigned 1:1 to receive ffr-guided pci using zotarolimus des or cabg.Patients who were assigned to the cabg group underwent surgery according to local routine at each participating center.Patients who were assigned to the ffr-guided pci group had all stenoses with an ffr of 0.80 or less treated with either a medtronic resolute integrity zotarolimus des or resolute onyx zotarolimus des.The primary end point of fame 3 was the composite of death from any cause, mi, stroke, or repeat revascularization at 1 year.At the time of the design of fame 3, a key secondary end point (the composite of death from any cause, mi, or stroke at 3 years) was pre-specified and is presented in this study.A total of 1500 patients with 3-vessel cad were randomly assigned at 48 sites to ffr-guided pci (757 patients) or cabg (743 patients).Baseline characteristics and angiographic characteristics were well-balanced between groups.39% of patients were admitted with an acute coronary syndrome.In the pci group, 24% of the lesions intended for treatment had an ffr >0.80.Patients who underwent pci had a mean of 3.7 des implanted.Clinical follow-up was performed at hospital discharge, 1 and 6 months, and 1, 2, and 3 years.Complete 3-year follow-up was achieved in > 96% of patients in both groups.At 3 years, there was no significant difference in the composite of death, mi, or stroke.Death from any cause was not different between groups and occurred in 4.1% of patients assigned to pci and 3.9% of patients assigned to cabg.Mi occurred in 7.0% of patients assigned to pci and in 4.2% of patients assigned to cabg.Stroke occurred in 1.6% of patients assigned to pci and in 2.0% of patients assigned to cabg.Repeat revascularization occurred more frequently in those randomized to pci compared with those randomized to cabg.The composite of death, mi, stroke, or repeat revascularization occurred in 18.6% of patients randomized to pci and in 12.5% of patients randomized to cabg.The percentage of patients with clinically relevant angina at 3 years was low and was not different between the groups.

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: 18442503
• MDR Text Key: 331867528
• Report Number: 9612164-2024-00049
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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?: Yes
• Date Manufacturer Received: 02/12/2024
• 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; Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White