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

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

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 'sex differences in delayed hospitalization in patients with non-st-segment elevation myocardial infarction undergoing new-generation drug-eluting stent implantation'.The aim of this non-randomized, multicenter, prospective cohort study was to compare the 3-year effects of sex differences in delayed hospitalization (symptom-to-door time [sdt], = 24 hours), on major clinical outcomes in patients with non-st-segment elevation myocardial infarction (nstemi) after new-generation drug-eluting stent (des) implantation.Data was taken from the korea ami registry-national institute of health (kamir-nih).Overall, 4593 patients with nstemi who underwent successful percutaneous coronary intervention (pci) using new-generation des were enrolled and classified into sdt <(><<)> 24 hours (n = 3317) and sdt = 24 hours (n = 1276) groups.These two groups were subdivided into male (group a [n = 2492] and group c [n = 849]) and female (group b [n = 825] and group d [n = 427]) subgroups.Medtronic resolute integrity des were among the des used during the study.The primary clinical outcomes were major adverse cardiac and cerebrovascular events (macce), defined as all-cause death, recurrent myocardial infarction (mi), repeat coronary revascularization, and stroke.Target lesion revascularization (tlr), target vessel revascularization (tvr), and non-tvr were included in the criteria for any repeat revascularization.The event rate of definite or probable stent thrombosis (st) was considered as the secondary clinical outcome.After conventional coronary angiography (cag) via a transfemoral or transradial approach, 200¿300 mg of aspirin, 300¿600 mg of clopidogrel, 180 mg of ticagrelor, and 60 mg of prasugrel were prescribed as the loading doses before pci.After pci, 100 mg of aspirin was recommended for all patients, combined 75 mg of clopidogrel once daily, 90 mg of ticagrelor twice daily, or 5¿10 mg of prasugrel once daily for a minimum of one year.The individual operators were able to choose the access site, revascularization strategy, and des without any restrictions.The 3-year clinical follow-up was through face-to-face interviews, phone calls, and chart reviews.After multivariable and propensity score-adjusted analyses, in-hospital mortalities were similar between the male and female groups in both the sdt <(><<)> 24 hours and sdt = 24 hours groups.However, during a 3-year follow-up period, in the sdt <(> <<)> 24 h group, all-cause death (p = 0.013 and p = 0.005, respectively) and cardiac death (p = 0.015 and p = 0.008, respectively) rates were significantly higher in the female group than those in the male group.Macce, non-cardiac death, recurrent mi, any repeat revascularization, stroke, and st rates were similar between the male and female groups and between the sdt <(><<)> 24 hours and sdt = 24 hours groups.

Manufacturer Narrative

Correction: title: sex differences in delayed hospitalization in patients with non-st-segment elevation myocardial infarction undergoing new-generation drug-eluting stent implantation year: 2023 reference: https://doi.Org/10.3390/jcm12051982 a2: average age a3: majority gender 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.

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 INTEGRITY 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: 18452193
• MDR Text Key: 332253456
• Report Number: 9612164-2024-00091
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 01/18/2024
• 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): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male