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

Model Number	9-ASD-030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
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 septal occluder was chosen for implant using a 12f amplatzer trevisio delivery system.During the procedure, while deploying the right atrial disc after the left atrial disc was deployed, the device completely detached from the delivery cable.The cable connection was checked during prep ad prior to deployment.The patient was subsequently transferred to cardiac surgery, where a surgical intervention was performed to remove the device and close the path.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 premature separation during procedure was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.A cine review was completed, stating "two still fluoro images were provided.The images do not show the premature detachment of the occluder, only after the occluder was released from the cable and embolized to the right atrium.One image was pre-detachment with the second image post detachment showing the embolized occluder." the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported premature separation could not be determined.A surgical intervention was a result of case-specific circumstances, as the device was removed and the septum was closed.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 30mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio delivery system.During the procedure, while deploying the right atrial disc after the left atrial disc was deployed, the device completely detached from the delivery cable.The cable connection was checked during prep ad prior to deployment.The patient was subsequently transferred to cardiac surgery, where a surgical intervention was performed to remove the device and close the path.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• 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: 23732797
• Report Number: 2135147-2025-07207
• Device Sequence Number: 9710276
• Product Code: MLV
• UDI-Device Identifier: 00811806010229
• UDI-Public: (01)00811806010229(17)300131(10)10710534
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 10710534
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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: 12 F AMPLATZER TREVISIO DELIVERY SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 55 KG