MAUDE Adverse Event Report: MEDTRONIC, INC EXPORT AP ASPIRATION CATHETER; CATHETER, EMBOLECTOMY

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

Patient Problems Arrhythmia (1721); Hemorrhage/Bleeding (1888); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/20/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: comparison of myocardial microcirculatory perfusion after catheter-administered intracoronary thrombolysis with anisodamine versus standard thrombus aspiration in patients with st-elevation myocardial infarction authors: yang fu, xin-shun gu, guo-zhen hao, yun-fa jiang, wei-ze fan, yan-ming fan, qing-min wei journal: catheterization and cardiovascular interventions year: 2019 reference: doi: 10.1002/ccd.28112.Average age, majority gender, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - comparison of myocardial microcirculatory perfusion after catheter-administered intracoronary thrombolysis with anisodamine versus standard thrombus aspiration in patients with st-elevation myocardial infarction - was submitted for review.The aim of the study was to evaluate efficacy, safety and feasibility of targeted intracoronary injection using pro-urokinase combined with anisodamine (tca) versus thrombus aspiration (ta) in st-elevation myocardial infarction (stemi) patients with high thrombus loads.Stemi patients receiving coronary artery angiogram (cag) or percutaneous coronary intervention (pci) with thrombus grade = 3 were randomly assigned to wither group.The primary endpoint was thrombosis in myocardial infarction (timi) rates and timi myocardial perfusion grade (tmpg) in the repeat cag on day 7 post initial procedure.The secondary endpoint was the 90-day rate of major adverse coronary events (mace) defined as cardiac death, reinfarction and malignant arrhythmia, and any bleeding complications.The enrolled patients were 1:1 randomized into either the tca or ta groups.The medtronic export ap aspiration catheter was used in the ta group.Two patients in the ta group were transferred to the tca group because the aspiration catheter failed to arrive at appropriate position to launch an aspiration, while 3 patients were eliminated from the tca group.In the end a total of 20 patients were in the tca group with 19 in the ta group.In primary pci for stemi patients with a high thrombus load, both of the two strategies included achieved a satisfactory effect on opening infarct related arteries and reducing thrombus loads.Tca appears to clear the thrombosis and restore myocardial perfusion more quickly and effectively than ta.When a 90-day follow-up was concluded, no difference in incidence of maces or stroke was found between the groups.The ta group recorded incidences of heart failure, malignant arrhythmias and minor bleeding, while the tca group had incidences of heart failure and minor bleeding only.

• Brand Name: EXPORT AP ASPIRATION CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11974742
• MDR Text Key: 267296234
• Report Number: 1220452-2021-00022
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/10/2021
• 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 Age: 63 YR