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

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

Patient Problems Myocardial Infarction (1969); Thrombosis (2100); Rupture (2208); Patient Problem/Medical Problem (2688)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

Average age.Majority gender.Date of publication.Journal article title: impact of killip classification on acute myocardial infarction: data from the saikuma registry.Eiji taguchi, yutaka konami, masayuki inoue, hiroto suzuyama, kazuhisa kodama, masayoshi yoshida, shinzo miyamoto, koichi nakao, tomohiro sakamoto.Heart vessels (2017) 32:1 439¿1447.Doi 10.1007/s00380-017-1017-0.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: therapeutic devices for acute myocardial infarction (ami) have evolved dramatically in recent years.However, the impact of the killip classification of ami outcomes in patients undergoing aggressive percutaneous coronary intervention remains unclear.We performed a 10-year retrospective review of 2062 patients diagnosed with ami, and divided the data into two 5-year intervals: 2005¿2009 (n = 1071), and 2010¿2014 (n = 991).No difference was observed in in-hospital mortality rate between the two periods (first period, 11.5% vs second period, 9.7%; p = 0.19).The incidence of stent thrombosis was not significantly different between the two periods, and very few thrombi occurred in patients who received second-generation drug-eluting stents (des) (0.98%: 5/511).In-hospital mortality due to stent thrombosis was high in the full cohort (15%).During the second period, in-hospital mortality was lower in killip class 4 patients, although the difference was not significant (59.1 vs 47.5%, p = 0.07).Multivariable logistic regression identified several factors that significantly affected in-hospital mortality, including age [odds ratio (or) 1.07], left main trunk (or 2.47), peak cpk value above 5000 iu/l (or 3.18), and killip class 4 (or 15.63).We evaluated trends in in-hospital mortality among patients with ami over a 10-year period.New des and the frequent use of mechanical support in patients with hemodynamic compromise tended to improve in-hospital mortality, but the effect was not significant.Notably, killip class 4 on admission was associated with an estimated 16-fold increased risk of in-hospital death.

• Brand Name: ENDEAVOR RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7995390
• MDR Text Key: 124702049
• Report Number: 9612164-2018-02883
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060033
• 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: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• 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: 09/27/2018
• 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: 70 YR