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 Insufficient Information (4580)

Event Date 01/01/2001

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature: article title: "impact of atrial septal defect closure on mortality in older patients".

Event Description

The article, "impact of atrial septal defect closure on mortality in older patients", was reviewed.The article presented a retrospective, single center to evaluate the mortality rates in older atrial septal defect (asd) patients with and without closure.Devices included in this study were cocoon and amplatzer septal occluder devices.The article concluded that asd closure demonstrated favorable outcomes in older patients.Age, nyha class, blood urea nitrogen (bun), right ventricular systolic pressure (rvsp), and asd closure were identified as independent factors linked to mortality in this population.[the primary and corresponding author was nithima ratanasit, mahidol university, 999 phutthamonthon sai 4 rd, salaya, phutthamonthon district, nakhon pathom 73170, thailand, with corresponding email: nithma.Rat@hotmail.Com] the time frame of the study was from 01 january 2001 to 31 january 2017.A total of 299 patients who received asd closure were included, of which it could not be confirmed how many received an abbott device.The average age was 55.1 years and the majority gender was female.Comorbidities included hypertension, hyperlipidemia, diabetes mellitus, stroke, coronary artery disease, atrial fibrillation, history of heart failure.

Manufacturer Narrative

Summarized patient outcomes/complications of impact of atrial septal defect closure on mortality in older patients were reported in a research article in a subject population with multiple co-morbidities including hypertension, hyperlipidemia, diabetes mellitus, stroke, coronary artery disease, atrial fibrillation, history of heart failure.Some of the complications reported was death this complication is 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.¿literature attachment: article title: impact of atrial septal defect closure on mortality in older patients.¿.

• 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: 19013989
• MDR Text Key: 339060836
• Report Number: 2135147-2024-01428
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 04/24/2024

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: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/24/2024
• 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): Death