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

Model Number	9-ASD-022
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 a 22mm amplatzer septal occluder was selected for implant to treat an atrial septal defect (asd) shunt.The asd was measured at 19.5mm under echocardiogram (echo).Sizing of the device was determined with a balloon and stop-flow technique.Angiography and echo were used during the procedure.A stability check was performed.Upon release of the occluder from the delivery cable the occluder embolized to the left atrium, causing a partial blockage.Attempts were made to snare the occluder but were unsuccessful.The patient was transferred to surgery where the occluder was surgically explanted and the asd was surgically closed.The user believed the device embolization was due to device undersizing.The patient remained hemodynamically stable throughout the procedure.The patient status was stable.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device migration (embolization), during the implant procedure was reported.A returned device assessment could not be performed as the device was not returned for analysis.Upon release of the occluder from the delivery cable the occluder embolized to the left atrium, causing a partial blockage.An attempt to snare the valve was unsuccessful.The procedure was converted to surgery where the occluder was surgically explanted, and the asd was surgically closed.Additionally, the imaging provided by the account were further reviewed by an abbott staff.The reviewer noted that ¿four cell phone images of tee were provided.Two images appear to show the final implanted occluder.The other two images were taken from a distance and are quite small and indistinct.Additional imaging would need to be provided to confirm the embolized device.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The physician believed the device embolization was due to device under sizing.However, the cause could not be conclusively determined.The reported medical intervention was a result of case-specific circumstances as the embolized device was snared and the asd was surgically closed.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: 21874876
• Report Number: 2135147-2025-02094
• Device Sequence Number: 7899701
• Product Code: MLV
• UDI-Device Identifier: 00811806010182
• UDI-Public: (01)00811806010182(17)281231(10)10189951
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/16/2025

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-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 10189951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male