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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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 22mm amplatzer septal occluder was chosen for implant using an 9f amplatzer treviso delivery system for an atrial septal defect (asd) closure procedure was performed under transesophageal echocardiography (tee) and fluoroscopy guidance.The atrial septal defect measured approximately 21¿22 mm, and device sizing was determined by balloon sizing using a 24 mm balloon.During the procedure, multiple devices were utilized due to difficulty achieving stable positioning, including 20 mm, 22 mm, and 24 mm occluders.The initially attempted 22 mm device could not be positioned despite multiple deployment techniques (lupv, rupv, and la deployment).A 20 mm device was then deployed but subsequently pulled through to the right atrium during the push/pull maneuver.A 24 mm device was deployed but was removed after it was noted to impinge on the mitral valve.A second attempt with a 22 mm device demonstrated no movement during push/pull testing, no valve impingement, good rim capture, and no residual defect.A stability check was performed, and no leak was detected.A 22 mm amplatzer septal occluder was ultimately selected and implanted using an unknown delivery system, and the device was placed and released.Shortly after release, and prior to the patient leaving the catheterization laboratory, immediate device migration was observed on tee and fluoroscopy.The device was reported to have shifted in position and turned perpendicular to the atrial septum while remaining within the septal region.The implanter indicated the cause of embolization was unknown.A 12-f amplatzer trevisio delivery system was inserted to facilitate removal, and a 10 mm snare was advanced to capture the migrated device.The device was secured by the right atrial pin, retracted into the catheter system, and removed successfully.Estimated blood loss was less than 30 ml, and the patient remained hemodynamically stable.The patient did not experience any rhythm changes or clinical symptoms, and no obstruction of blood flow was observed.Percutaneous retrieval via the groin was considered an emergency intervention to prevent permanent impairment or death.The device was successfully retrieved without incident.The patient remained stable throughout the procedure and was referred for surgical closure at a later date, which has not yet been determined.
Additional Manufacturer Narrative
An event of device migration during the implant 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 available information, the cause of the reported event could not be conclusively determined.It is possible that procedural condition and challenging anatomy could have contributed to this event.However, this cannot be confirmed.The reported unexpected medical intervention of removing the device was a result of case-specific circumstances as the device was scheduled to be snared.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2026, a 22mm amplatzer septal occluder was chosen for implant using an9f amplatzer treviso delivery system for an atrial septal defect (asd) closure procedure was performed under transesophageal echocardiography (tee) and fluoroscopy guidance.The atrial septal defect measured approximately 21¿22 mm, and device sizing was determined by balloon sizing using a 24 mm balloon.During the procedure, multiple devices were utilized due to difficulty achieving stable positioning, including 20 mm, 22 mm, and 24 mm occluders.The initially attempted 22 mm device could not be positioned despite multiple deployment techniques (lupv, rupv, and la deployment).A 20 mm device was then deployed but subsequently pulled through to the right atrium during the push/pull maneuver.A 24 mm device was deployed but was removed after it was noted to impinge on the mitral valve.A second attempt with a 22 mm device demonstrated no movement during push/pull testing, no valve impingement, good rim capture, and no residual defect.A stability check was performed, and no leak was detected.A 22 mm amplatzer septal occluder was ultimately selected and implanted using an unknown delivery system, and the device was placed and released.Shortly after release, and prior to the patient leaving the catheterization laboratory, immediate device migration was observed on tee and fluoroscopy.The device was reported to have shifted in position and turned perpendicular to the atrial septum while remaining within the septal region.The implanter indicated the cause of embolization was unknown.A 12-f amplatzer trevisio delivery system was inserted to facilitate removal, and a 10 mm snare was advanced to capture the migrated device.The device was secured by the right atrial pin, retracted into the catheter system, and removed successfully.Estimated blood loss was less than 30 ml, and the patient remained hemodynamically stable.The patient did not experience any rhythm changes or clinical symptoms, and no obstruction of blood flow was observed.Percutaneous retrieval via the groin was considered an emergency intervention to prevent permanent impairment or death.The device was successfully retrieved without incident.The patient remained stable throughout the procedure and was referred for surgical closure at a later date, which has not yet been determined.It was later confirmed that 20mm and 24mm amplatzer septal occluder were events of mis-sizing.

• 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: 24283833
• Report Number: 2135147-2026-00729
• Device Sequence Number: 13252469
• Product Code: MLV
• UDI-Device Identifier: 00811806010182
• UDI-Public: (01)00811806010182(17)290131(10)10208942
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/29/2026

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 Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 10208942
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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 Age: 3 YR
• Patient Sex: Male
• Patient Weight: 21 KG