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

Model Number	9-ASD-015
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	02/02/2026
Type of Reportable Event	Malfunction
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) 2026, a 15mm amplatzer septal occluder was chosen for a procedure.During procedure, after the echocardiogram (echo) was performed and the measurement with an 18-mm balloon was obtained, the size of the prosthesis was defined as 15mm.After opening the device, the physician followed the step-by-step assembly process as recommended by abbott.At the moment of releasing the first disc in the left atrium, the prosthesis exhibited a cobra shape.Several attempts were made to correct the shape, without success.Subsequently, the entire system was withdrawn and the prosthesis was immersed in warm saline for three minutes.It was then reloaded, and several additional positioning attempts were performed, again without success.The prosthesis no longer responded in a natural and appropriate manner, making it necessary to open a new prosthesis.A new17mm amplatzer septal occluder was chosen and completed the procedure.There was no injury to the patient was not reported.
Additional Manufacturer Narrative
An event of device deformity was reported.Imaging was received from the field showing the device deploying into a cobra-like deformation.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 information received, the cause of the reported incident could not be conclusively determined.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 15mm amplatzer septal occluder was chosen for a procedure.During procedure, after the echocardiogram (echo) was performed and the measurement with an 18-mm balloon was obtained, the size of the prosthesis was defined as 15mm.After opening the device, the physician followed the step-by-step assembly process as recommended by abbott.At the moment of releasing the first disc in the left atrium, the prosthesis exhibited a cobra shape.Several attempts were made to correct the shape, without success.Subsequently, the entire system was withdrawn and the prosthesis was immersed in warm saline for three minutes.It was then reloaded, and several additional positioning attempts were performed, again without success.The prosthesis no longer responded in a natural and appropriate manner, making it necessary to open a new prosthesis.A new17mm amplatzer septal occluder was chosen however, due to the child¿s anatomy, it was not possible to anchor the prosthesis and the procedure was aborted.There was a delay, but it was not clinically significant.There was no injury to the patient was not reported.The patient was discharged and will be referred for surgery.

• 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: 24469612
• Report Number: 2135147-2026-01202
• Device Sequence Number: 10332078
• Product Code: MLV
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/07/2026

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-015
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 10425181
• Was Device Available for Evaluation?: Yes
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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
• Patient Sex: Unknown