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

Model Number	9-ASD-030
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 a 30mm amplatzer septal occluder was selected for implant using a 12f amplatzer torqvue delivery system to treat an atrial septal defect (asd).Transthoracic echocardiogram (tte) and digital subtraction angiography (dsa) were used during the procedure.The asd was measured at 26mm.The devices were prepared per instructions for use (ifu).The cable connection was checked during device preparation and prior to deployment.During the procedure the occluder prematurely disconnected from the delivery cable when the cable was gently pulled back to the delivery system.The occluder caused a partial blockage of blood flow in the left pulmonary artery.An attempt was made to snare the occluder but was unsuccessful.The patient underwent surgery to remove the device and close the asd.The patient status was stable.
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 on (b)(6) 2025 a 30mm amplatzer septal occluder was selected for implant using a 12f amplatzer torqvue delivery system to treat an atrial septal defect (asd).Transthoracic echocardiogram (tte) and digital subtraction angiography (dsa) were used during the procedure.The asd was measured at 26mm.The devices were prepared per instructions for use (ifu).The cable connection was checked during device preparation and prior to deployment.During the procedure the occluder prematurely disconnected from the delivery cable when the cable was gently pulled back to the delivery system.The occluder caused a partial blockage of blood flow in the left pulmonary artery.An attempt was made to snare the occluder but was unsuccessful.The patient underwent surgery to remove the device and close the asd.The patient status was stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device was reported.The device was returned for analysis and the device met functional and dimensional specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.The cause of the reported incident could not be conclusively determined.The reported unexpected medical intervention and surgical interventions were the result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23097311
• Report Number: 2135147-2025-05288
• Device Sequence Number: 21138779
• Product Code: MLV
• UDI-Device Identifier: 00811806010229
• UDI-Public: (01)00811806010229(17)291031(10)10615387
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 10615387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: 12F AMPLATZER TORQVU [9-ITV12F45/80, LOT: 10605018].
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown