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 Thrombosis/Thrombus (4440); Heart Block (4444)

Event Date 09/01/2013

Event Type  Injury  

Event Description

The article "clinical and procedural characteristics of successful transcatheter device closure of ostium secundum atrial septal defect in symptomatic children weighing <15 kg: a retrospective study spanning one decade from south>india" was reviewed.The article presented a retrospective single center study, to evaluate the feasibility of transcatheter atrial septal defect device closure in patients less than 15 kg, as well as to assess complication rates and the reasons for unsuccessful device closure.Devices mentioned include amplatzer atrial septal defect (asd) occluder.The article concluded that *conclusion*.[the primary author and corresponding author was shohiab u.R.Mirza at , christian medical college vellore, india with corresponding email shohiab.Riyaz@gmail.Com.The time frame of the study was september 2013 to february 2022.A total of 81 patients were included in this study, of which 20 received an abbott device.Out of 81 patients, the median age was 3.The majority gender was female.Median weight was 12 kg.Comorbidities include failure to thrive, recurrent lower respiratory tract infection, pulmonary stenosis, persistent left superior vena cava, mitral valve prolapse, ventricular septal defect, dyspnea on exertion, right axis deviation, incomplete right bundle branch block, right ventricular hypertrophy, complete right bundle branch block, first degree atrioventricular block, junctional rhythm, tricuspid regurgitation, pulmonary artery hypertension.Peri and post procedural complications include right common femoral artery thrombosis, complete heart block, intervention, residual shunt.

Manufacturer Narrative

The additional patient effect of malfunction reported in the article is captured under a separate medwatch report.B3 - as this event is from a literature review, the event date is estimated.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Summarized patient outcomes/complications of clinical and procedural characteristics of successful transcatheter device closure of ostium secundum atrial septal defect in symptomatic children weighing <15 kg: a retrospective study spanning one decade from south>india were reported in a research article in a subject population with multiple co-morbidities including failure to thrive, recurrent lower respiratory tract infection, pulmonary stenosis, persistent left superior vena cava, mitral valve prolapse, ventricular septal defect, dyspnea on exertion, right axis deviation, incomplete right bundle branch block, right ventricular hypertrophy, complete right bundle branch block, first degree atrioventricular block, junctional rhythm, tricuspid regurgitation, pulmonary artery hypertension.Some of the complications reported were right common femoral artery thrombosis, complete heart block, intervention, residual shunt 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 clinical and procedural characteristics of successful transcatheter device closure of ostium secundum atrial septal defect in symptomatic children weighing <15 kg: a retrospective study spanning one decade from south>india.

• 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: 19201579
• MDR Text Key: 341267061
• Report Number: 2135147-2024-01873
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P000039
• 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: 05/24/2024

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
• Device Catalogue Number: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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