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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: transcatheter closure of secundum atrial septal defects in pediatric patients: a 15-year single- center experience.The udi number is not known as the part and lot number were not provided.

Event Description

The article, "transcatheter closure of secundum atrial septal defects in pediatric patients: a 15-year single- center experience", was reviewed.The article presented a retrospective, single center study on the center's experience with transcatheter closure of atrial septal defects (asds) over the last 15 years.Devices included amplatzer septal occluder, occlutech figulla asd occluder, lifetech ceraflex, and solysafe septal occluder.The article concluded that with appropriate patient and device selection, transcatheter closure is a safe and effective treatment for secundum asd and should be the first treatment of choice.[the primary and corresponding author was eser dogan, department of pediatric cardiology, faculty of medicine, ege university, izmir, turkey, with corresponding email: eserdogan86@hotmail.Com].The time frame of the study was from january 2007 to january 2023.A total of 323 patients were included in this study, of which 277 (85.8%) received an abbott device.The average age was 8.08 years and the majority gender was female.Comorbidities included atrial septal defect (asd) including single or multiple secundum asds.

Manufacturer Narrative

Summarized patient outcomes/complications of transcatheter closure of secundum atrial septal defects in pediatric patients: a 15-year single- center experience were reported in a research article in a subject population with multiple co-morbidities including atrial septal defect (asd) including single or multiple secundum asds.Some of the complications reported were device embolization, surgical 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.Literature article title: transcatheter closure of secundum atrial septal defects in pediatric patients: a 15-year single- center experience.

• 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: 19163644
• MDR Text Key: 340838389
• Report Number: 2135147-2024-01805
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 05/16/2024

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: 03/29/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/16/2024
• 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