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

Catalog Number UNK AMPLATZER OCCLUDER

Device Problems Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Myocardial Infarction (1969)

Event Date 05/01/2008

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effect of malfunction reported in the article is captured under a separate medwatch report.Summarized patient outcomes/complications of amplatzer septal occluder were reported in a research article in a subject population with multiple co-morbidities including coronary artery fistulas, congenital cardiovascular anomalies, prior cardiac surgery, heart murmur, atrial septal defect, pulmonary stenosis, bicuspid aortic valve, hypertrophic cardiomyopathy, ventricular septal defect, aortic coarctation, coronary artery bypass graft, aortic/mitral valve replacement surgery, hypertension, diabetes, dyslipidemia, obese, smoking.Some of the complications reported were residual shunt, myocardial infarction, inflammation (pericarditis), surgical intervention, and hospitalization; 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.  per the instructions for use, stated "indication and usage: the amplatzer¿ septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration.Patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular (rv) volume overload (ie, 1.5:1 degree of left-to-right shunt or rv enlargement).".

Event Description

The article, ¿coronary artery fistulas: a 12-year single-center experience¿, was reviewed.The article presented a retrospective, single center study aimed to investigate the clinical and angiographic characteristics of coronary artery fistulas (cafs) in a population of portuguese patients undergoing invasive coronary angiography (ica), as well as their assessment and management strategies.Devices included in this study were amplatzer vascular plug ii (n=3), amplatzer vascular plug iv (n=1), medtronic mvp-3q micro vascular plug®(n=2), amplatzer septal occluder (n=1) and amplatzer ductal occluder (n=1).The article concluded the prevalence of cafs was 0.2%, the majority originated from the left anterior descending artery (lad), and the pulmonary artery was the main drainage site.In patients undergoing intervention, both percutaneous and surgical techniques were safe and effective.[the primary and corresponding author was sofia torres, cardiology department, centro hospitalar universitário de são joão, porto, portugal, with corresponding email: sofiacardosotorres@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: 17877313
• MDR Text Key: 324998024
• Report Number: 2135147-2023-04332
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• 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