MAUDE Adverse Event Report: Abbott Medical Amplatzer Septal Occluder; Transcatheter Septal Occluder

Model Number	9-ASD-020
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 20mm amplatzer septal occluder was chosen for implant using 9f amplatzer trevisio intravascular delivery system.During the procedure, in an attempt to position the left disc of the occluder parallel to the interatrial septum, it was noted that the device was exposed and recaptured into the 9f trevisio catheter approximately three times, after which it opened in a cobra shape configuration.The device was then removed, placed in warm saline, and returned to its original shape.It was reloaded into the same sheath and reintroduced into the patient; however, it continued to open in a cobra shape configuration.The deformed device was never released from the delivery cable while inside the patient.There was no angulation or kink noted in the delivery system.The device was replaced with an 18mm amplatzer septal occluder; however, the procedure was completed unsuccessfully, as the physician was unable to align the device with the septum.According to the physician, the left atrium was small, and the aortic rim was short.Therefore, there was not enough space or support to maneuver the prosthesis into the correct release angle.The 18mm amplatzer septal occluder did not present any issues.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.
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.

• 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: 50802009
• Report Number: 2135147-2026-06273
• Device Sequence Number: 10548936
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 10687377
• 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: 08/22/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 9-ATV09F45/80 Lot: 10916847
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 55 LB