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

Model Number	9-ASD-MF-030
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 30mm amplatzer cribriform device was chosen for implant using an 8f amplatzer torqvue delivery system.During the procedure, the preparation of the device was normal.However, the right atrial (ra) disc appeared slightly bulbous when the prep was repeated.The team decided to proceed, thinking that with temperature change and delivery sheath against the disc it may change.The anatomy was challenging due to an aneurysmal pfo septum.When the left atrial (la) disc was released, it initially appeared bulbous.After recapturing and repositioning the la disc, it formed naturally.Later, upon releasing and positioning the ra disc at the septum, it caused the la disc to deform.This occurred multiple times.The device was placed in a normal position but it was not released from the cable as the device was deformed.The procedure was completed using a non-abbott device.The deformed device was never released from the delivery cable while inside the patient.There was no interaction with the cardiac structures during deployment and no angulation/kink noticed in the delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Event or Problem Description
It was reported that on (b)(6) 2025, a 30mm amplatzer cribriform device was chosen for implant using an 8f amplatzer torqvue delivery system.During the procedure, the preparation of the device was normal.However, the right atrial (ra) disc appeared slightly bulbous when the prep was repeated.The team decided to proceed, thinking that with temperature change and delivery sheath against the disc it may change.The anatomy was challenging due to an aneurysmal pfo septum.When the left atrial (la) disc was released, it initially appeared bulbous.After recapturing and repositioning the la disc, it formed naturally.Later, upon releasing and positioning the ra disc at the septum, it caused the la disc to deform.This occurred multiple times.The device was placed in a normal position but it was not released from the cable as the device was deformed.The procedure was completed using a non-abbott device.The deformed device was never released from the delivery cable while inside the patient.There was no interaction with the cardiac structures during deployment and no angulation/kink noticed in the delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.The cause of the reported device deformity could not be conclusively determined.Additionally, the observed bent damage on the returned loader have resulted from damage during use and/or shipping or transportation-related stress in the return to abbott.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23431440
• Report Number: 2135147-2025-06265
• Device Sequence Number: 13145662
• Product Code: MLV
• UDI-Device Identifier: 00811806010304
• UDI-Public: (01)00811806010304(17)270228(10)8379959
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-MF-030
• Device Catalogue Number: 9-ASD-MF-030
• Device Lot Number: 8379959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8F TORQVUE (9-ITV08F45/80)
• Patient Age: 30 YR
• Patient Sex: Female