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

Catalog Number 9-PFO-025

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

Patient Problems Stroke/CVA (1770); Movement Disorder (4412)

Event Date 06/18/2023

Event Type  Injury  

Event Description

Clinical information: crd_961 - pfo japan pas, patient site id:(b)(6).It was reported that a 25mm amplatzer pfo occluder was implanted on (b)(6) 2021.P2y12 inhibitor (antiplatelet) and direct oral anticoagulants (doac) were prescribed post-procedure.On (b)(6) 2023, during a 2-year patient follow-up no issues were detected and the patient was only prescribed antiplatelet.On (b)(6) 2023 the patient experienced an ischemic stroke and presented with paralysis in the upper and lower extremities and aphasia.The patient was rushed to the hospital and administered edaravone.The symptoms were reportedly resolved.It was believed that the stroke was unrelated to the device and procedure.The patient status was stable.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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: 19203843
• MDR Text Key: 341295218
• Report Number: 2135147-2024-01889
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)251130(10)7769239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

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: 9-PFO-025
• Device Lot Number: 7769239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2020
• 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): Disability; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Weight: 46 KG