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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Atrial Fibrillation (1729); Erosion (1750); Stroke/CVA (1770); Fever (1858); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Perforation (2001); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422); Pericardial Effusion (3271); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/1999

Event Type  malfunction  

Event Description

The article, "outcome of transcatheter atrial septal defect closure in a nationwide cohort", was reviewed.The article presented a retrospective, multicenter study to evaluate the long-term outcome of transcatheter-closed atrial septal defects (asds).The devices included in this study were amplatzer asd occluder, amplatzer cribriform occluder, amplatzer pfo occluder, figulla, helex, and starflex.The article concluded that after transcatheter (tc) closure of asd, patients had a higher risk of new-onset atrial fibrillation and migraine than controls without asd.As novel findings, they found an increased risk for ischemic heart disease, atrioventricular (av) conduction disorders, and ventricular fibrillation/tachycardia.[(b)(6)] the time frame of the study was rom 1999 to 2019.A total of (b)(4) received an abbott device.The average age was 37.9 years, and the average gender was female.Comorbidities included concomitant congenital heart defect, atrial septal defect, atrial fibrillation, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, migraine, stroke, transient ischemic attack, floppy septum, multi-fenestrated atrial septal defect.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article titled "outcome of transcatheter atrial septal defect closure in a nationwide cohort".

Manufacturer Narrative

Summarized patient outcomes/complications of transcatheter-closed atrial septal defects (asds) were reported in a research article "outcome of transcatheter atrial septal defect closure in a nationwide cohort" in a subject population with multiple co-morbidities including concomitant congenital heart defect, atrial septal defect, atrial fibrillation, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, migraine, stroke, transient ischemic attack, floppy septum, multi-fenestrated atrial septal defect.Some of the complications reported were embolization, bleeding, erosion, ruptured septum (perforation), coronary occlusion, pericardial effusion, fever, allergic reaction, pneumonia, stroke, heart failure, atrial fibrillation, ventricular fibrillation, heart block, pacemaker implant (surgical intervention), hospitalization; 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: 18440951
• MDR Text Key: 332620967
• Report Number: 2135147-2024-00043
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/29/2024
• 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): Life Threatening; Hospitalization; Required Intervention; Disability