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	Arrhythmia (1721)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 34mm amplatzer septal occluder was chosen for implant using an unknown delivery system.Device sizing was determined using balloon sizing.The procedure was performed under transesophageal echocardiography (tee) and fluoroscopic guidance.The occluder was positioned within the atrial septal defect; however, difficulty was encountered when attempting to detach the device from the delivery cable.After the device was eventually released, it shifted from its intended position off the superior vena cava (svc) rim, which was identified on tee imaging.The implanter reported that the shift occurred at the time of release from the delivery cable, and this was believed to be the cause of the device migration.A stability check was performed following deployment.A residual leak measuring 1¿3¿mm around the right atrial disc was observed during intraprocedural assessment.The patient experienced a rhythm change and subsequently developed hemodynamic instability with interaction between the device and the tricuspid valve.Given the device malposition, an attempt was made to reposition the occluder by snaring the pin on the right atrial disc.During this maneuver, the device became dislodged into the right atrium and then migrated to the tricuspid valve, where it lodged, resulting in partial obstruction of blood flow.Multiple percutaneous retrieval attempts were unsuccessful.Due to the device location and associated hemodynamic compromise, retrieval was considered an emergency procedure to prevent permanent impairment and/or death.It was subsequently determined that surgical intervention would be required to retrieve the embolized device and surgically close the atrial septal defect.
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 specifications.Based on the information received, the cause of the embolization was believed to be the under sizing of the valve.The patient effect of arrhythmia appears to be cascading effect reported device embolization.The reported surgical intervention was a case circumstance as atrial septal defect was surgically closed.There were no complaints associated with any other devices from the lot.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) 2026, a 34mm amplatzer septal occluder was chosen for implant using an unknown delivery system.Device sizing was determined using balloon sizing.The procedure was performed under transesophageal echocardiography (tee) and fluoroscopic guidance.The occluder was positioned within the atrial septal defect; however, difficulty was encountered when attempting to detach the device from the delivery cable.After the device was eventually released, it shifted from its intended position off the superior vena cava (svc) rim, which was identified on tee imaging.The implanter reported that the shift occurred at the time of release from the delivery cable, and this was believed to be the cause of the device migration.A stability check was performed following deployment.A residual leak measuring 1¿3 mm around the right atrial disc was observed during intraprocedural assessment.The patient experienced a rhythm change and subsequently developed hemodynamic instability with interaction between the device and the tricuspid valve.Given the device malposition, an attempt was made to reposition the occluder by snaring the pin on the right atrial disc.During this maneuver, the device became dislodged into the right atrium and then migrated to the tricuspid valve, where it lodged, resulting in partial obstruction of blood flow.Multiple percutaneous retrieval attempts were unsuccessful.Due to the device location and associated hemodynamic compromise, retrieval was considered an emergency procedure to prevent permanent impairment and/or death.It was subsequently determined that surgical intervention would be required to retrieve the embolized device and surgically close the atrial septal defect.

• 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: 24618007
• Report Number: 2135147-2026-01687
• Device Sequence Number: 13345790
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: (01)00811806010243(17)260131(10)7850249
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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 Expiration Date: 01/31/2026
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 7850249
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2021
• 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 Age: 23 YR
• Patient Sex: Female