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

Model Number	9-VSD-MUSC-012
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
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
A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of advancement difficulty and device deformity was reported.The investigation confirmed the device met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event advancement difficulty could not be determined.It was indicated that the papillary muscle may have prevented a normal deployment.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.It should be noted that the amplatzer muscular vsd occluder, instruction for use (ifu), states: "do not release the occluder from the delivery cable if the occluder does not conform to its original configuration or if occluder position is unstable or interferes with any adjacent cardiac structure (such as aortic valve).Advance the delivery sheath to recapture the occluder and redeploy.If the occluder position is still unsatisfactory, recapture the occluder and replace it with a new occluder or abort the procedure." in this case, it is unknown if the ifu violation caused or contributed to the reported complaint; therefore, a letter will not be created.

• Brand Name: AMPLATZER MUSCULAR VSD 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: 22925998
• Report Number: 2135147-2025-04885
• Device Sequence Number: 18418826
• Product Code: MLV
• UDI-Device Identifier: 00811806011820
• UDI-Public: (01)00811806011820(17)270630(10)8561960
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040040
• 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): 11/17/2025

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-VSD-MUSC-012
• Device Catalogue Number: 9-VSD-MUSC-012
• Device Lot Number: 8561960
• 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: 11/06/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 63 KG