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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "a case of infectious infective endocarditis after amplatzer septal occluder placement", was reviewed.This research article is a retrospective single center experience to assess the use of amplatzer septal occluder in women in their 50's and the occurrence of infectious endocarditis.Devices involved in this study include the amplatzer atrial septal occluder and dacron patch.In one patient, two atrial septal occluder closures were performed for two residual atrial septal occluder 5years ago.The patient was hospitalized because of fever without any trigger and hepatic abscess was indicated by computerized tomography (ct) scan.Transesophageal echocardiography showed growth of extended spectrum beta-lactamase (esbl) producing escherichia coli in blood, urine, liver abscess puncture, and all culture tests revealed 10mm length and 8mm length of the two amplatzer septal occluder on the right atrial and left atrial sides, respectively.The patient was treated with antibiotics for 6 weeks after the diagnosis of infectious infective endocarditis and negative blood culture.[surgery].The approach was to perform a median sternotomy, heart-lung machine, and cardiac arrest.The right atrium was incised, and the two amplatzer septal occluder were confirmed.After removing the amplatzer septal occluder vegetation in the central of vegetation, the neointima of mesh segment was dissected, the dacron patch between the two amplatzer septal occluder was dissected, and the neointima of the left atrium was also removed from the left atrium side, and amplatzer septal occluder of the surrounding tissue was removed afterwards, and the defect hole was sutured and closed with autopericardium.Tricuspid annulus suture was added and completed.The course was uneventful and the patient was discharged on postoperative day 24.Antibiotic administration was preceded by surgery, which resulted in a reduction in the size of the tax, with no postoperative reinfection.The article concluded that their center experienced a rare case of infectious endocarditis 5 years after atrial septal occluder placement.[the primary author of this article is taiki ito, physician, daiki ito, hokkaido university hospital, cardiovascular surgery, 5 chome kita 14 jonishi, kita ward, sapporo, hokkaido 060-8648, japan].

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer septal occluder after five years was reported in a research article in a subject population with multiple co-morbidities including demonstrated intracardiac thrombi.Some of the complications reported infectious infective endocarditis.These complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 16021092
• MDR Text Key: 305872799
• Report Number: 2135147-2022-02655
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 02/13/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female