MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number	9-ASD-MF-025
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
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) 2024, a 25mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for a patent foramen ovale (pfo) closure using a 9f amplatzer trevisio intravascular delivery system.The sizing of the device was determined by transesophageal echocardiogram (tee).The device was successfully implanted after stability test.On (b)(6) 2024, a transesophageal echocardiogram (tee) was performed and it was noted that the device was no longer at the intra atrial septum place.The device was found at the abdominal aorta level.The physician used a snare and alligator forceps to catch the device at the abdominal aorta level and it was possible to pull the device inside a 16f long introducer and it got removed.The patient was reported stable and discharged.
Additional Manufacturer Narrative
H6 - removed medical device problem code 2017 (improper or incorrect procedure or method) and added code 1494 (off-label use).An event of device deformity was reported.A returned device inspection could not be performed as the device was not returned for analysis.Information from the field indicated that snare and alligator forceps to catch the device at the abdominal aorta level and it was possible to pull the device inside a 16f long introducer and it got removed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported device deformity could not be conclusively determined.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.The reported improper or incorrect procedure or method was due to user did not exchange for a new device.There were no complaints associated with any other devices from the lot.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, "embolized devices must be removed.Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath." this did not caused the reported event, the letter will not be sent.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• 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: 21079976
• Report Number: 2135147-2025-00117
• Device Sequence Number: 20939477
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: (01)00811806010298(17)270930(10)8698432
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 8698432
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown