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

Catalog Number	9-ASD-015
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Movement Disorder (4412)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem 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 5-year-old, 16.5 kg, female patient with a fenestrated atrial septal defect.It was reported that on an unknown date, a 15mm amplatzer septal occluder was implanted.A small residual shunt was noted during procedure.It was then reported shortly after procedure, the patient developed dizziness and fatigue.Magnetic resonance imaging (mri) was performed, however, results were normal and non-pathologic.The patient later described experiencing headaches, gradually improving but still documented several years after the procedure.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.[(b)(6)].
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
As reported in a research article, "headaches in children after transcatheter device closure of atrial septal defects: a single centre experience", on an unknown date, a 15mm amplatzer septal occluder was implanted in a 5-year-old, 16.5 kg, female patient with a fenestrated atrial septal defect.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.Peri- and post-procedural complications included dizziness (movement disorder), fatigue, headaches, residual shunt.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: 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: 18748644
• Report Number: 2135147-2024-00787
• Device Sequence Number: 11688129
• Product Code: MLV
• UDI-Device Identifier: 00811806010120
• UDI-Public: 00811806010120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ASD-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 17 KG