MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Septal Occluder; Transcatheter Septal Occluder

Model Number	9-ASD-014
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.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 14mm amplatzer septal occluder was implanted using a 8f amplatzer trevisio delivery system.The defect was reported to have been sized at 18 mm using a sizing balloon (sb), with device sizing determined based on fluoroscopy and transesophageal echocardiography (toe) measurements; it was additionally noted that a 12 mm asd was initially missized prior to implantation of the 14 mm device.The procedure was performed under toe and fluoroscopic guidance, and a stability check was reportedly performed.The patient subsequently presented for a routine follow-up on (b)(6) 2026, at which time it was identified that the device had embolized.It was clarified that the device had completely dislodged from the implant site, with suspected missizing considered a potential contributing factor.This finding was confirmed on a routine chest x-ray, which demonstrated that the device had migrated to a position just below the renal arteries.It was further reported that the embolized device did not result in partial or complete obstruction of blood flow.It was further reported that a retrieval procedure was planned, with the patient scheduled to undergo device removal in the emergency room on (b)(6) 2026.The retrieval was described as a planned elective procedure rather than an emergency intervention.
Event or Problem Description
It was reported that on (b)(6) 2026, a 14mm amplatzer septal occluder was implanted using a 8f amplatzer trevisio delivery system.The defect was reported to have been sized at 18 mm using a sizing balloon (sb), with device sizing determined based on fluoroscopy and transesophageal echocardiography (toe) measurements; it was additionally noted that a 12 mm asd was initially missized prior to implantation of the 14 mm device.The procedure was performed under toe and fluoroscopic guidance, and a stability check was reportedly performed.The patient subsequently presented for a routine follow-up on (b)(6) 2026, at which time it was identified that the device had embolized.It was clarified that the device had completely dislodged from the implant site, with suspected missizing considered a potential contributing factor.This finding was confirmed on a routine chest x-ray, which demonstrated that the device had migrated to a position just below the renal arteries.It was further reported that the embolized device did not result in partial or complete obstruction of blood flow.It was further reported that a retrieval procedure was planned, with the patient scheduled to undergo device removal in the emergency room on (b)(6) 2026.The retrieval was described as a planned elective procedure rather than an emergency intervention.The device got removed via percutaneous retrieval with large cardiac snare.
Additional Manufacturer Narrative
An event of device embolization was reported.Possible causes for device embolization include device over-sizing, device under-sizing or positioning issue due to patient anatomy.Information from the field indicated that after the procedure, it was noted that the occluder had embolized, with transthoracic echocardiography (tte) confirming that the device had completely dislodged from the implant site with suspected missizing considered a potential contributing factor.A returned device assessment could not be performed as the device was not returned for analysis.Based on the available information, the cause for the reported device embolization could not be determined.It is possible that procedural circumstances (mis sizing of the occluder) contributed to the event.However, this cannot be determined.The reported medical intervention was a result of case specific circumstances, as the device was snared.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: health effect-clinical code: health effect- impact code: 4624.

• 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 ; +1(651)756-5400
• MDR Report Key: 25466312
• Report Number: 2135147-2026-03935
• Device Sequence Number: 10284712
• Product Code: MLV
• UDI-Device Identifier: 00811806010113
• UDI-Public: (01)00811806010113(17)300228(10)10750945
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 10750945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 132 LB