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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 09/11/2023

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 case study of a 15-year-old patient with a secundum-type atrial septal defect with 25-mm stretched defect diameter.It was reported on an unknown date, a 28mm amplatzer septal occluder was implanted.Post-procedurally, a trivial residual shunt was noted via transthoracic echocardiography (tte).It was reported a month later an unknown date, tte noted a 15mm pericardial effusion at the apex and next to the left ventricle.The patient was treated with applied diuretic and non-steroidal anti-inflammatory therapy, but the pericardial effusion persisted.Three months post intervention, the pericardial effusion had become significant, hemoglobin levels dropped, and erosion of the atrial or aortic wall was suspected.A pericardiocentesis was performed and 330ml of fluid was drained.Transesophageal echocardiography revealed close position of discs to the aortic wall and dilated transverse sinus of the pericardial sack.Consequent surgical procedure detected a 5mm perforation of the left atrial wall damaged adventitia and exposed media of the aortic wall.The device was surgically explanted, and the atrial septal defect was closed with a pericardial patch and four stitches were used to stabilize the aortic and left atrial walls.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: (b)(6).

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.As reported through a literature review a 15-year-old patient with a secundum-type atrial septal defect with 25-mm stretched defect diameter and a 28mm amplatzer septal occluder was implanted.It was reported a month later, tte noted a 15mm pericardial effusion at the apex and next to the left ventricle.The patient was treated with applied diuretic and non-steroidal anti-inflammatory therapy, but the pericardial effusion persisted.Three months post intervention, the pericardial effusion had become significant, hemoglobin levels dropped, and erosion of the atrial or aortic wall was suspected.A pericardiocentesis was performed and 330ml of fluid was drained.Transesophageal echocardiography (tee) revealed close position of discs to the aortic wall and dilated transverse sinus of the pericardial sack.The device was surgically explanted, and the atrial septal defect was closed with a pericardial patch and four stitches were used to stabilize the aortic and left atrial walls.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.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.

• 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: 17873296
• MDR Text Key: 324960140
• Report Number: 2135147-2023-04327
• 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): Required Intervention; Hospitalization
• Patient Age: 15 YR