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

Model Number	9-ASD-012
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); 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	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 12mm amplatzer septal occluder (aso) was chosen for implantation into a pseudoaneurysm neck present on the outside wall of the left ventricle.A greater than 80cm delivery sheath was required to reach the defect, so a delivery cable from an amplatzer trevisio was used with a non-abbott terumo sheath.The sheath was advanced to the defect.Once the aso exited the tip of the sheath, it deformed into a cobra shape.The aso was removed and the deformation was massaged out.The aso was re-loaded with tension and attempted to be deployed again but deformed into cobra shape once more.It was thought papillary strands may have prevented a normal deployment or interaction with the non-abbott sheath.A 12mm amplatzer ventricular septal defect occluder (vsd) was then chosen for implantation utilizing the same non-abbott 7f delivery sheath.The vsd was hard to advance through the sheath, so the sheath was exchanged for a non-abbott 7f shuttle sheath.The 12mm vsd was deployed but was deformed (elongated and bulbous) possibly due to papillary muscle again.12mm vsd removed and exchanged for 10mm vsd with the same delivery system.The 10mm vsd was deployed but insufficiently closed the defect as it was too small so it was removed.When removing, it pulled a shred of the delivery sheath inner lumen.Finally, a 11mm aso was implanted successfully.The patient remained hemodynamically stable throughout the procedure.There were no reported patient consequences.
Additional Manufacturer Narrative
An event of device deformity during implant was reported.Information from field indicated that it was thought papillary strands may have prevented a normal deployment or interaction with the non-abbott sheath.The investigation confirmed the device met functional specifications when analyzed at abbott.The returned loader was kinked.The device history record was reviewed to ensure that each manufacturing and inspection operation was perform.Based on information received, anatomical factor may have contributed to device deformation; however, the exact cause could not be conclusively determined.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, "the amplatzer¿ septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration." codes removed: medical device problem code: 2017 improper or incorrect procedure or method.

• 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): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22925932
• Report Number: 2135147-2025-04884
• Device Sequence Number: 9162743
• Product Code: MLV
• UDI-Device Identifier: 00811806010090
• UDI-Public: (01)00811806010090(17)280430(10)9067366
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/27/2025

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-012
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 9067366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 63 KG