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

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

Patient Problems Myocardial Infarction (1969); Ventricular Fibrillation (2130); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 09/05/2022

Event Type  Injury  

Manufacturer Narrative

Title: effect of direct stenting on microvascular dysfunction during percutaneous coronary intervention in acute myocardial infarction: a randomized pilot study.Authors: byung gyu kim, sung woo cho, jongkwon seo, gwang sil kim, moo-nyun jin, hye young lee, young sup byun and byung ok kim.Journal name: journal of international medical research year: 2022 reference: doi.Org/10.1177/03000605221127888.Average age, majority gender and date of publication patient 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.

Event Description

A journal article was submitted for review titled "effect of direct stenting on microvascular dysfunction during percutaneous coronary intervention in acute myocardial infarction: a randomized pilot study".The aim of this study was to investigate the efficacy of direct stenting without pre-dilatation in reducing microvascular dysfunction and improving clinical outcomes compared with conventional percutaneous coronary intervention (pci) in patients with st segment elevation myocardial infarction (stemi) using the index of microcirculatory resistance (imr).Between march 2011 and december 2012 seventy-two patients who presented with a stemi and underwent pci were randomly assigned to the direct stenting (ds) without pre-dilatation (n=34) or conventional stenting (cs) with pre-dilatation groups (n=38).In patients in the cs group, balloon angioplasty was carried out before the stenting step.Manual thrombus aspiration (ta) was performed in 65 of these patients.Stents used during the procedure included the medtronic endeavor resolute and resolute integrity coronary drug eluting stents (des), as well as other non-medtronic des.Lesions treated included the left anterior descending artery, left circumflex artery and right coronary artery.The primary endpoint of the study was myocardial perfusion assessment using post-pci imr values.The secondary endpoints were the timi myocardial perfusion (tmp) grade, st-segment resolution, left ventricular function recovery, and the occurrence of major adverse cardiovascular events (mace), which were a composite of cardiac death, target-vessel related myocardial infarction (mi), and target-lesion revascularization (tlr).In the ds group, direct stenting failed for three patients for whom pre-dilation was necessary when the stent could not be advanced through the target lesion.Cardiogenic shock during pci occurred in one patient in the ds group and in four patients in the cs group.In 11 patients, the imr could not be measured because of the development of cardiogenic shock, ventricular fibrillation, or no-reflow during the procedure.The post-pci imr value was not different between the ds and cs groups.Between baseline and the 6-month follow up, no difference was observed in the change in the left ventricular ejection fraction in the two groups.The mean clinical follow-up duration was 71.8 +/- 36.0 months.There was no difference in the cumulative incidence of mace between the cs and ds groups.The overall rates of mace during the follow-up were 1 tlr in the ds group, and 1 cardiac death, 1 target vessel-related mi and 1 tlr in the cs group.

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.

• Brand Name: RESOLUTE INTEGRITY 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: 16362145
• MDR Text Key: 309383307
• Report Number: 9612164-2023-00631
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• 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: 58 YR
• Patient Sex: Male