MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number UNK AMPLATZER FSO CRIBRIFORM

Device Problems Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Myocardial Infarction (1969); Transient Ischemic Attack (2109); Ventricular Fibrillation (2130)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Literature article: comparison of three echo-guidance techniques in percutaneous patent foramen ovale closure for stroke prevention: conventional transoesophageal, microprobe transoesophageal and intracardiac echocardiography investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "comparison of three echo-guidance techniques in percutaneous patent foramen ovale closure for stroke prevention: conventional transoesophageal, microprobe transoesophageal and intracardiac echocardiography".

Event Description

The article, "comparison of three echo-guidance techniques in percutaneous patent foramen ovale closure for stroke prevention: conventional transoesophageal, microprobe transoesophageal and intracardiac echocardiography", was reviewed.The article presented a prospective, single center study to compare the safety and efficacy of intracardiac echocardiography-guided and microprobe transoesophageal echocardiography-guided patent foramen ovale closure under local anaesthesia with transoesophageal echocardiography-guided patent foramen ovale closure under general anaesthesia.Devices included in the study were amplatzer pfo occluder, amplatzer multi-fenestrated septal occluder "cribriform", and occlutech figulla flex ii pfo occluder.The article concluded preliminary real-world experience suggests good efficacy and safety with intracardiac echocardiography and microprobe transoesophageal echocardiography guidance compared with conventional transoesophageal echocardiography guidance for percutaneous transcatheter patent foramen ovale closure in recurrent stroke prevention.[the primary and corresponding author was gilles montalescot, sorbonne université, action study group, inserm umrs_1166, institut de cardiologie, hôpital pitié-salpêtrière, ap-hp, 75013 paris, france, with corresponding email: gilles.Montalescot@aphp.Fr] the time frame of the study was from february 2018 to december 2019.A total of 194 patients were included in this study, of which 146 received an abbott device (amplatzer pfo: n=137, 70.6%; cribriform: n=9, 4.6%).The average age was 48.4 years and the average gender was male.Comorbidities included smoking, hypertension, diabetes mellitus, hypercholesterolaemia, coronary artery disease, peripheral ischemia, venous thromboembolic disease, arrhythmia, migraine, septal anomaly (small-large shunt, atrial septal aneurysm).

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer septal occluder- cribriform were reported in a research article in a subject population with multiple co-morbidities including smoking, hypertension, diabetes mellitus, hypercholesterolaemia, coronary artery disease, peripheral ischemia, venous thromboembolic disease, arrhythmia, migraine, and septal anomaly (small-large shunt, atrial septal aneurysm).Some of the periprocedural complications reported were residual shunt, stroke, and myocardial infarction and post-procedural complications included stroke, transient ischemic attack, atrial fibrillation, supraventricular arrhythmia; 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.Based on the available information, the root cause of the reported incidents could not be conclusively determined.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• 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: 18012896
• MDR Text Key: 327144382
• Report Number: 2135147-2023-04690
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER FSO CRIBRIFORM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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): Life Threatening; Disability