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

Model Number	9-ASD-018
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 18mm amplatzer septal occluder was chosen for implant using a 8f amplatzer torqvue delivery system.During the procedure, when the device was opening in the left atrium (la), a cobra deformation was noted.The deformed device has not been released and it was taken out, reshaped and then re-advanced again.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 9f amplatzer torqvue delivery system was chosen and same device was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was some delay but there were no complications.The patient was reported discharged.On (b)(6) 2025, the patient came for follow-up and a small residual left-right shunt which was not present at discharge has been noted.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of advancement difficulty through delivery system, device deformity, and residual shunt was reported.A returned device assessment could not be performed as the device was not returned for analysis.However, six still fluoroscopic images received from the field showed the device deformed inside the patient.Two additional fluoroscopic images showed the device released with a normal shape.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported incidents could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please per the instructions for use, the recommended size delivery system for use with an 18mm amplatzer septal occluder is 8f delivery system.Codes removed: component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4118 type of investigation not yet determined; investigation findings: investigation conclusions: 11 conclusion not yet available.
Event or Problem Description
It was reported that on (b)(6) 2025, a 18mm amplatzer septal occluder was chosen for implant using a 8f amplatzer torqvue delivery system.During the procedure, the device was not possible to pass through the 8f and they changed into a 9f.When the device was opening in the left atrium (la), a cobra deformation was noted.The deformed device has not been released and it was taken out, reshaped and then re-advanced again.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.The device was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was some delay but there were no complications.The patient was reported discharged.On 27 february 2025, the patient came for follow-up and a small residual left-right shunt was noted.The physician mentioned no shunt was noted at the time of discharge.The shunt was acceptable at this stage.No additional information was provided.

• 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: 21574546
• Report Number: 2135147-2025-01223
• Device Sequence Number: 12848782
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: (01)00811806010151(17)290630(10)10418941
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• 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): 04/24/2025

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-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 10418941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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: 8FAMPLATZER TORQVUE DELIVERY SYSTEM, (B)(6).
• Patient Sex: Unknown