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

Catalog Number 9-ASD-014

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Endocarditis (1834); Fever (1858); Rash (2033); Cognitive Changes (2551); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 04/28/2023

Event Type  Injury  

Manufacturer Narrative

Literature article: early infective endocarditis associated with an amplatzer atrial septal occluder device in a 14-year-old male.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "early infective endocarditis associated with an amplatzer atrial septal occluder device in a 14-year-old male", was reviewed.The article presented a case study of a 14-year-old male with an atrial septal defect (asd).It was reported that on an unknown date, a 14mm amplatzer atrial septal occluder was implanted.The patient underwent an adjustment of his dental brace one week after asd closure.Four weeks following asd closure, the patient presented with fever, altered mental status, and rash.Physical examination revealed multiple erythematous, non-tender, pinpoint-macular lesions on his palms and soles, consistent with janeway lesions.Two consecutive transthoracic echocardiograms (tte) were negative for vegetations.Magnetic resonance imaging (mri) of the brain showed multiple small embolic infarcts and ophthalmologic evaluation revealed bilateral intra-retinal hemorrhages.Transesophageal echocardiography (tee) demonstrated an echogenic mass measuring 10 × 6 mm attached to the left atrial disc of the asd device without any residual shunt.Subsequently, blood culture grew staphylococcus aureus.A decision was made to surgically remove the 14mm amplatzer occluder and close the asd with a pericardial patch.The article concluded that the effectiveness of antibiotic prophylaxis for infective endocarditis (ie) is debated and is reflected in the various published guidelines.Based on several studies, the single dose antibiotic pre-procedure has a effectiveness rate of 46¿91%.Despite the failure to prevent ie in the index case, they continue to recommend antibiotic prophylaxis for 6 months after the procedure as per the american heart association (aha) guidelines.[the primary and corresponding author was gurumurthy hiremath, university of minnesota masonic children¿s hospital, 2450 riverside ave, minneapolis, mn 55454, usa, with corresponding email: hiremath@umn.Edu].

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer septal occluder were reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were fever, cognitive changes, rash, surgical intervention, hospitalization, endocarditis, thrombus and septic emboli.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.Literature attachment: article title "early infective endocarditis associated with an amplatzer atrial septal occluder device in a 14-year-old male".

• 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): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18646679
• MDR Text Key: 334613260
• Report Number: 2135147-2024-00510
• Device Sequence Number: 1
• Product Code: MLV
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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: 14 YR
• Patient Sex: Male