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

Model Number	9-ASD-009
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	09/08/2025
Type of Reportable Event	Malfunction
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) 2025, a 9mm amplatzer septal occluder was chosen for implant using a 8f amplatzer trevisio intravascular delivery system.During the procedure, the cobra device deformation occurred while expanding the device within the patient's anatomy.The device was removed from the patient's anatomy prior to being released from the delivery cable.A new 9mm amplatzer septal occluder was chosen using the same delivery system, a cobra device deformation occurred again.The deformed device were retrieved outside the patient prior to release from the delivery cable.It was observed that a thrombus had developed on the 8f delivery system.The thrombus did not have unusual or fiber like appearance.It was noted that the sheath was in the patient for a significant period of time due to the deformations.The activated clotting time (act) level was noted as 250 during the procedure, however it was noted that it was difficult to prolong and additional heparin was administered.The patient did not have any hematological disorders or systemic illness to contribute to the hypercoagulability.The procedure was completed using an 8mm amplatzer septal occluder and new deliver system.It was reported that there was no clinically significant delay throughout the procedure and the patient remained hemodynamically stable throughout the procedure.
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.One photo was received from the field showing the deformation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 9mm amplatzer septal occluder was chosen for implant using an 8f amplatzer trevisio intravascular delivery system.During the procedure, the cobra device deformation occurred while expanding the device within the patient's anatomy.The device was removed from the patient's anatomy prior to being released from the delivery cable.A new 9mm amplatzer septal occluder was chosen using the same delivery system, a cobra device deformation occurred again.The deformed device were retrieved outside the patient prior to release from the delivery cable.It was observed that a thrombus had developed on the 8f delivery system.The thrombus did not have unusual or fiber like appearance.It was noted that the sheath was in the patient for a significant period of time due to the deformations.The activated clotting time (act) level was noted as 250 during the procedure, however it was noted that it was difficult to prolong and additional heparin was administered.The patient did not have any hematological disorders or systemic illness to contribute to the hypercoagulability.The procedure was completed using an 8mm amplatzer septal occluder and new deliver system.It was reported that there was no clinically significant delay throughout the procedure and the patient remained hemodynamically stable throughout the procedure.

• Brand Name: AMPLATZER SEPTAL 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: 23214020
• Report Number: 2135147-2025-05678
• Device Sequence Number: 8853645
• Product Code: MLV
• UDI-Device Identifier: 00811806010069
• UDI-Public: (01)00811806010069(17)271231(10)8864624
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/11/2025

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-009
• Device Catalogue Number: 9-ASD-009
• Device Lot Number: 8864624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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 DS (10524643,9-ATV7F45/80).
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 48 KG