MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

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

Patient Problems Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/01/2011

Event Type  Injury  

Manufacturer Narrative

Summarized patient outcomes/complications of mitral regurgitation outcomes after transcatheter atrial septal defect closure were reported in a research article in a subject population with multiple co-morbidities including hypertension, dyslipidemia, diabetes mellitus, coronary artery disease, atrial fibrillation.Some of the complications reported were heart failure, hospitalization, supraventricular arrhythmia, newly prescribed diuretics (unexpected medical intervention), worsening mitral regurgitation these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Literature attachment: article title "mitral regurgitation outcomes after transcatheter atrial septal defect closure".

Event Description

The article, ¿mitral regurgitation outcomes after transcatheter atrial septal defect closure¿, was reviewed.The article presented retrospective, single center study to elucidate mitral regurgitation (mr) outcomes and predictors of worsening mr after transcatheter atrial septal defect (asd) closure.Devices included in this study were amplatzer septal occluder (abbott, st.Paul, mn, usa) and occlutech figulla flex ii asd occluder (occlutech gmbh, jena, germany).The article concluded that worsening mr after transcatheter asd closure might depend on mitral valve (mv) leaflet findings and annulus size in patients with long-standing persistent atrial fibrillation.[the primary and corresponding author was michiyo yamano, department of cardiovascular medicine, graduate school of medical science, kyoto prefectural university of medicine, kajii-cho 465, kawaramachi-hirokoji, kamigyo-ku, kyoto 602-8566, japan, with corresponding email: m.Yamano823@gmail.Com].

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17999681
• MDR Text Key: 326445629
• Report Number: 2135147-2023-04638
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization