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

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Myocardial Infarction (1969); Embolism/Embolus (4438)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

An article "closure or medical therapy of patent foramen ovale in cryptogenic stroke: prospective case series", was reviewed.This research article is a prospective single center experience to compare interventional and medical patent foramen ovale (pfo) management in cryptogenic ischemic stroke (is)/transient ischemic attack (tia) patients below and above 60 years.Amplatzer pfo occluder was associated with the study.The article concluded that high-risk pfo patients greater than 60 years who underwent pfo-closure had similar is recurrence rates than those who received medical therapy alone (mta).Mta seems the appropriate treatment for low-risk pfo.The primary and correspondence author of the article is sven poli, md, department of neurology & stroke, eberhard, hoppe-seyler str.3 tübingen, germany 72076 , with the email: sven.Poli@uni-tuebingen.De.

Manufacturer Narrative

As reported in a research article, 146 patients underwent patent foramen ovale (pfo) closure, 145 had successful device implantation.One implantation was unsuccessful due to extreme long-channel pfo.Events of ischemic stroke, intracranial hemorrhage, transient ischemic attack, systemic embolism, myocardial infarction, atrial fibrillation, major bleeding, and residual shunt were reported.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.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11846238
• MDR Text Key: 251369995
• Report Number: 2135147-2021-00199
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR