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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Erosion (1750); Endocarditis (1834); Cardiac Perforation (2513); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 09/01/1995

Event Type  Injury  

Event Description

The article, ¿long-term follow-up of percutaneous secundum-type atrial septal defect closure using amplatzer septal occluder since 1995: a single-centre study¿, was reviewed.The article presented, a retrospective single center study.To evaluate long-term results of percutaneous closure of secundum-type atrial septal defect, using amplatzer septal occluder with the follow-up to 25 years.Device included in this study was only amplatzer septal occluder.The article concluded percutaneous closure of secundum-type atrial septal defect, using amplatzer septal occluder is a safe and effective procedure.Accounting for a very low incidence of major complications in the long-term follow-up.[the primary and corresponding author was peter olejnik, national institute of cardiovascular diseases, pediatric cardiac center, bratislava, slovakia, with corresponding email: petoolejnik@gmail.Com].

Manufacturer Narrative

Literature attachment: article title: long-term follow-up of percutaneous secundum-type atrial septal defect closure, using amplatzer septal occluder since 1995: a single-centre study.The additional, patient effect of malfunctions reported in the article are captured under separate emdr report.Summarized patient outcomes/complications of amplatzer septal occluder were reported in a research article.In a subject population with multiple co-morbidities including atrial septal defect.Some of the complications reported were device embolization, thrombus, erosion, infective endocarditis, residual shunt, arrhythmias, pericardial effusion, cardiac perforation, surgical intervention, hospitalization, and unexpected medical intervention.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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 17873273
• MDR Text Key: 324961204
• Report Number: 2135147-2023-04325
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• 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: 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): Hospitalization; Required Intervention