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

Catalog Number UNK AMPLATZER PFO OCCLUDER

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

Patient Problems Air Embolism (1697); Atrial Fibrillation (1729); Stroke/CVA (1770); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided the additional patient effect of malfunction reported in the article is captured under a separate medwatch report.Summarized patient outcomes/complications of percutaneous patent foramen ovale (pfo) closure using 2 widely used double-disc occluders were reported in a research article "amplatzer or figulla flex ii occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure" in a subject population with multiple co-morbidities including hypertension, diabetes, dyslipidemia, active smoking, prior stroke, thrombophilia, atrial fibrillation, cryptogenic stroke, peripheral embolism, prophylactic, migraine with aura, platypnea orthodeoxia syndrome, decompression illness, right to left shunt.Some of the complications reported were air embolism, stroke, unexpected medical intervention, recurrent thromboembolic events, atrial fibrillation; 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 analysisna.

Event Description

The article, "amplatzer or figulla flex ii occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure", was reviewed.The article presented an observational, single center study to compare results of percutaneous patent foramen ovale (pfo) closure using 2 widely used double-disc occluders.Devices included in this study were amplatzer pfo occluder and occlutech figulla flex ii pfo occluder.The article concluded that pfo closure is safe and effective when performed with either the self-expanding abbott amplatzer orocclutech figulla flex ii pfo occluder.[the primary and corresponding author was mathias wolfrum, cardiology division, heart center lucerne, luzerner kantonsspital,spitalstrasse 16, 6000 luzern, switzerland, with corresponding e-mail: mathias.Wolfrum@luks.Ch] the time frame of the study was from february 2017 to december 2022.A total of 193 patients were included in the study, of which 120 (61.5%) received an abbott device.The average age was 51.7 years and the gender majority was male.Comorbidities included hypertension, diabetes, dyslipidemia, active smoking, prior stroke, thrombophilia, atrial fibrillation, cryptogenic stroke, peripheral embolism, prophylactic, migraine with aura, platypnea orthodeoxia syndrome, decompression illness, right to left shunt.

• Brand Name: AMPLATZER PFO 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: 18924220
• MDR Text Key: 337907591
• Report Number: 2135147-2024-01209
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER PFO OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• 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; Life Threatening; Disability