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

Catalog Number 9-ASD-009

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Headache (1880); Movement Disorder (4412)

Event Date 01/18/2024

Event Type  Injury  

Event Description

The article, "headaches in children after transcatheter device closure of atrial septal defects: a single centre experience", was reviewed.The article presented a case study of a 15-year-old, 74.4 kg, female patient with an atrial septal defect and known migraine headaches.It was reported that on an unknown date, a 9mm amplatzer septal occluder was chosen for implant to occlude an atrial septal defect with a maximal defect diameter of 12mm.It was reported after implant, there was a tiny residual shunt through the device.It was then reported 18 days post-procedure on an unknown date, the patient was readmitted for migraine headache.Magnetic resonance imaging (mri) was done as the patient experienced hemiplegia, however, findings were non-specific and non-pathologic.Post-procedure medication aspirin was changed to clopidogrel.The article concluded that the study suggested a minimal estimate of 15% as the incidence of headache in children who undergo tdc.This estimate can inform counseling prior to tdc.Determination of the true incidence will require focused prospective data collection.[the primary and corresponding author was joshua griesman, the hospital for sick children, toronto, ontario, canada, with corresponding email: joshua.Griesman@sickkids.Ca].

Manufacturer Narrative

As reported in a research article, "headaches in children after transcatheter device closure of atrial septal defects: a single centre experience", a case study of a 15-year-old, 74.4 kg, female patient with an atrial septal defect and known migraine headaches presented with a tiny residual shunt through the device post implant and was readmitted for migraine headache 18 days post procedure.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from the field indicated that a 9mm amplatzer septal occluder was chosen for implant to occlude an atrial septal defect with a maximal defect diameter of 12mm please note per the instructions for use, "once the diameter of the defect is determined, select a device size equal to or 1 size larger than the diameter of the defect.".

• 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: 18705722
• MDR Text Key: 335377560
• Report Number: 2135147-2024-00658
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• 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; Disability
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 74 KG