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

Catalog Number 9-ASD-024

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

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: atrial septal defect, pulmonary arterial hypertension, and diastolic left heart failure: when 3 players come into the game.

Event Description

The article, "atrial septal defect, pulmonary arterial hypertension, and diastolic left heart failure: when 3 players come into the game", was reviewed.The article presented a case study of a 48-year-old female patient with pulmonary arterial hypertension and an atrial septal defect (asd).It was reported that on an unknown date, a 24mm amplatzer septal ocluder was chosen for implant.Prior to procedure, transesophageal echocardiography (tee) showed 2 asds, 1 (16×23 mm) secundum type.And 1 (12×15 mm) at the junction of the superior vena cava and right upper pulmonary vein.The 24mm amplatzer occluder was implanted in the larger asd with the smaller asd kept open as a "pop-off valve".Four weeks post-procedure on an unknown date, the patient presented with worsening dyspnea and pulmonary congestion.Right-left heart catheterization showed less l-r shunting, persistently low systemic cardiac output, markedly increased systemic vascular resistance and lv filling pressures.A decision was made to administer losartan (50mg bid) and torsemide.The patient reportedly recovered to new york heart association class ii.[the primary and corresponding author was tobias rutz, service of cardiology, lausanne university hospital and university of lausanne, rue du bugnon 46, 1011 lausanne, switzerland, with corresponding email: tobias.Rutz@chuv.Ch].

Manufacturer Narrative

As reported in a research article, atrial septal defect, pulmonary arterial hypertension, and diastolic left heart failure: when 3 players come into the game.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.Literature attachment: article title "atrial septal defect, pulmonary arterial hypertension, and diastolic left heart failure: when 3 players come into the game".

• 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: 19107014
• MDR Text Key: 340170929
• Report Number: 2135147-2024-01690
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 48 YR
• Patient Sex: Female