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 Angina (1710); Dyspnea (1816); Endocarditis (1834); Fever (1858); Unspecified Infection (1930); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/11/2023

Event Type  Injury  

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 18-year-old patient with atrial septal defect and amplatzer septal occluder was implanted.It was reported 12 years post-procedure, the patient presented with fever, chest pain, dyspnoea, elevated c-reactive protein, and positive hemoculture.The patient was treated with targeted antibiotic therapy but shortly after presented with hemodynamic instability.Transthoracic echocardiography (tte) imaged significant vegetation at the right and left side of the device, at the anterior mitral valve cusp, and at the region of the non-coronary aortic valve cusp, whose damage led to severe aortic valve regurgitation.A decision was made to surgically explant the amplatzer septal occluder and secundum-type atrial septal defect was closed with a pericardial patch.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.

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 an 18-year-old patient with atrial septal defect.It was reported on an unknown date, an unknown amplatzer septal occluder was implanted.It was reported 12 years post-procedure, the patient presented with fever, chest pain, dyspnoea, elevated c-reactive protein, and positive hemoculture.The patient was treated with targeted antibiotic therapy but shortly after presented with hemodynamic instability.Transthoracic echocardiography (tte) imaged significant vegetation at the right and left side of the device, at the anterior mitral valve cusp, and at the region of the non-coronary aortic valve cusp, whose damage led to severe aortic valve regurgitation.A decision was made to surgically explant the amplatzer septal occluder and secundum-type atrial septal defect was closed with a pericardial patch.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.[(b)(6)].

• 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: 17872824
• MDR Text Key: 324941918
• Report Number: 2135147-2023-04323
• 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: 18 YR