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

Catalog Number	9-PFO-025
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2135147-2023-03477
• Device Sequence Number: 8901881
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8F TREVISIO DELVIERY SYSTEM (LOT: 8873827)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown