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

Model Number	9-ASD-034
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 34 mm amplatzer septal occluder was chosen for implant using a 12f delivery system in a 37-year-old patient diagnosed with atrial septal defect (asd).The diagnosis was confirmed by transesophageal echocardiography, which measured the defect at approximately 22 mm with adequate rims.The patient was brought into the operating room for percutaneous closure under general anesthesia.During the procedure, measurement by echocardiographer was noted at 28 mm.Stability of the device was confirmed using the valsalva maneuver, and proper positioning of the rims within the device was achieved.The device was then successfully released.At the 48-hour postoperative follow-up, on (b)(6) 2025, a transthoracic echocardiogram identified migration of the device into the right atrium.The device had completely dislodged from the implant site.The implanter indicated that the posterior rim was possibly more floppy.No rhythm changes were observed during the procedure, and no leak was detected around the lobe of the device.The patient exhibited no clinical signs or symptoms during or after the event.There were no difficulties during implantation, and no recaptures or repositioning were required.No residual shunt was noted.The patient was subsequently taken to cardiovascular surgery, where the device was removed and surgical intervention was performed using a pericardial patch.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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 34 mm amplatzer septal occluder was chosen for implant using a 12f delivery system in a 37-year-old patient diagnosed with atrial septal defect (asd).The diagnosis was confirmed by transesophageal echocardiography, which measured the defect at approximately 22 mm with adequate rims.Device sizing was determined using balloon sizing in combination with echocardiographic imaging and transthoracic echocardiography (tte) was used during the procedure.The patient was brought into the operating room for percutaneous closure under general anesthesia.During the procedure, measurement by echocardiographer was noted at 28 mm.Stability of the device was confirmed using the valsalva maneuver, and proper positioning of the rims within the device was achieved.The device was then successfully released.At the 48-hour postoperative follow-up, on (b)(6) 2025, a transthoracic echocardiogram identified migration of the device into the right atrium.The device had completely dislodged from the implant site.The implanter indicated that the posterior rim was possibly floppier.No rhythm changes were observed during the procedure, and no leak was detected around the lobe of the device.The patient exhibited no clinical signs or symptoms during or after the event.There were no difficulties during implantation, and no recaptures or repositioning were required.No residual shunt was noted.The patient was subsequently taken to cardiovascular surgery, where the device was removed and surgical intervention was performed using a pericardial patch.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 device embolization was reported.An image was received from the field showing 4 operators looking at imaging.A returned device assessment could not be performed as the device was not returned for analysis.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 device embolization could not be determined.Surgical interventions were results of case specific circumstances, as the device was surgically removed and the asd was closed via pericardial patch.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Codes removed: health effect-clinical code.

• 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: 23824988
• Report Number: 2135147-2025-07452
• Device Sequence Number: 20103791
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: (01)00811806010243(17)280131(10)8887448
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 8887448
• 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: 11/22/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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: Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female