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

Catalog Number 9-PFO-025

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6)2023, a 25mm amplatzer patent foramen ovale (pfo) occluder (lot: 8902531) was implanted into a pfo utilizing a 8f trevisio delivery system (lot: 8873827).Sizing was determined via anatomical features but exact measurements were not completed.After deployment the device then dislodged and embolized.The device was snared and removed from the patient.The retrieval was considered an emergency procedure.A replacement 35mm amplatzer pfo occluder (lot: 7952852) was then implanted successfully with a 9f trevisio delivery system (lot: 8807488).The patient remained hemodynamically stable throughout the procedure.The patient was reported to be stable and discharged.

Manufacturer Narrative

An event of device embolization upon deployment requiring emergency retrieval was reported.Field indicated the implanter believed that mis-sizing was the cause of embolization/migration.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "device size selection: transesophageal echocardiography (tee) or intracardiac echocardiography (ice) is required to measure the distance from the defect to the aortic root, and the distance from the defect to the superior vena cava orifice.Size the defect such that the radius of the right atrial disc will not exceed the lesser of the two measurements, except in the case of an atrial septal aneurysm, where consideration should be given to placing a larger occluder in an effort to cover the aneurysm.Refer to the device selection section.

• 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: 17481473
• MDR Text Key: 320657717
• Report Number: 2135147-2023-03477
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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: 8902531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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
• Treatment: 8F TREVISIO DELVIERY SYSTEM (LOT: 8873827)
• Patient Outcome(s): Required Intervention