MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Model Number MF Septal Occluder Cribriform

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient had junctional rhythm with bradycardia in the immediately after the occluder was implanted and upon removal of the device the occluder was found to be covered in clots.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device or additional patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "sinus node recovery after explantation of amplatzer septal occluder: a word of caution", was reviewed.The research article presents a case study of a (b)(6) month old boy, who weighed (b)(6) kg.Co-morbidities included duplication of short arm of chromosome 3 and dandy-walker syndrome.The patient underwent hybrid closure of multiple atrial septal defects ii with a 25mm amplatzer cribriform occluder.The atrial septum was multi-fenestrated, with the largest defect measuring 7.5 mm in diameter, and at least 2 other small defects were identified.The patient¿s baseline heart rhythm was sinus.The patient developed persistent junctional rhythm with bradycardia in the immediate post-procedure period.Isoproterenol was used to counteract this bradycardia.Repeat attempts at weaning isoproterenol resulted in recurrence of his bradycardia and persistence of junctional rhythm.The device itself appeared to be in a good position with no residual shunt.Three days after the initial procedure, the patient was taken to the operating room and through a vertical axillary thoracotomy and using normothermic cardiopulmonary bypass, we were able to visualize the device, which appeared to occupy the majority of the right atrium.The device had multiple clots on both its right and left atrial surfaces, which were most likely related to a combination of a slow rhythm and absence of the atrial kick.The device was removed without difficulty, and a bovine pericardial patch was used to close the asds after transforming them into one large defect placed permanent atrial epicardial pacemaker leads in case a permanent pacemaker would be needed later.The patient had an uncomplicated postoperative course, and regained normal sinus rhythm 3 days later.The patient was discharged 10 days after the initial procedure without needing a permanent pacemaker.The article concluded that the avoidance of using large septal occluder devices, discrepant to the size of the atrial cavities of the child, and while sinus node dysfunction is a rare occurrence, removal of the device should be strongly considered if this complication is encountered.(b)(6).

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14493500
• MDR Text Key: 292593527
• Report Number: 2135147-2022-00309
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: 00811806010298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MF Septal Occluder Cribriform
• Device Catalogue Number: 9-ASD-MF-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• 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): Required Intervention
• Patient Age: 13 MO
• Patient Sex: Male
• Patient Weight: 6 KG