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

Model Number	9-ASD-026
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
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 that on (b)(6) 2025, a 26mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio delivery system for atrial septal defect (asd) closure in a 24-year-old patient with a defect size ranging from 14 to 24 mm.Sedation was administered, and the asd was accessed using a non-abbott catheter and a corowire.An amplatzer super stiff wire was introduced through the non - abbott catheter and positioned in the superior pulmonary vein.Fluoroscopic imaging was used to confirm wire placement.Transesophageal echocardiography (tee) was intentionally deferred for later use.The delivery sheath and occluder were prepared, with all pre-deployment criteria met: the sheath was confirmed to be free of air, and the junction test between the delivery cable and occluder was successfully completed.The delivery sheath was advanced over the amplatzer wire into the left atrium and positioned within the pulmonary vein.During the connection of the device to the sheath, slight left atrial pressure was observed.No backbleeding was initially noted; however, a minor positional adjustment of the sheath resulted in minimal backbleeding.The occluder was connected to the sheath and advanced into the left atrium.A connection test was performed under fluoroscopic guidance, confirming attachment to the delivery cable.Tee was still not utilized at this stage.The left disc of the device was retracted to the septum, but adequate contact was not achieved.A repositioning attempt was made toward the left anterior lobe.The device was then fully deployed into the left atrium, as per the operator¿s usual technique.A subsequent repositioning attempt was made, and successful placement at the septum was confirmed via fluoroscopy and operator assessment.Tee was then introduced to verify device positioning.During this evaluation, device embolization occurred, with migration into the right atrium and subsequently into the vena cava.The device had completely dislodged from the implant site and no leak was observed around the lobe of the device during the procedure.An attempt to stabilize the device using a coronary balloon was unsuccessful.Multiple attempts to retrieve the device using a snare drum also failed.The patient was referred to a specialized heart center for further management.
Event or Problem Description
It was reported that on (b)(6) 2025, a 26mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio delivery system for atrial septal defect (asd) closure in a 24-year-old patient with a defect size ranging from 14 to 24 mm.Sedation was administered, and the asd was accessed using a non-abbott catheter and a corowire.An amplatzer super stiff wire was introduced through the non - abbott catheter and positioned in the superior pulmonary vein.Fluoroscopic imaging was used to confirm wire placement.Transesophageal echocardiography (tee) was intentionally deferred for later use.The delivery sheath and occluder were prepared, with all pre-deployment criteria met: the sheath was confirmed to be free of air, and the junction test between the delivery cable and occluder was successfully completed.The delivery sheath was advanced over the amplatzer wire into the left atrium and positioned within the pulmonary vein.During the connection of the device to the sheath, slight left atrial pressure was observed.No backbleeding was initially noted; however, a minor positional adjustment of the sheath resulted in minimal backbleeding.The occluder was connected to the sheath and advanced into the left atrium.A connection test was performed under fluoroscopic guidance, confirming attachment to the delivery cable.Tee was still not utilized at this stage.The left disc of the device was retracted to the septum, but adequate contact was not achieved.A repositioning attempt was made toward the left anterior lobe.The device was then fully deployed into the left atrium, as per the operator¿s usual technique.A subsequent repositioning attempt was made, and successful placement at the septum was confirmed via fluoroscopy and operator assessment.Tee was then introduced to verify device positioning.During this evaluation, device embolization occurred, with migration into the right atrium and subsequently into the vena cava.The device had completely dislodged from the implant site and no leak was observed around the lobe of the device during the procedure.An attempt to stabilize the device using a coronary balloon was unsuccessful.Multiple attempts to retrieve the device using a snare drum also failed.The patient was referred to a specialized heart center for further management.The defect was closed surgically.
Additional Manufacturer Narrative
An event of device embolization was reported.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.Interventions were results of case-specific circumstances, as the device was attempted to be snared, the device was removed surgically, and the septal defect 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: 23660844
• Report Number: 2135147-2025-06987
• Device Sequence Number: 13042502
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: (01)00811806010205(17)300630(10)10940392
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 10940392
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Female