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

Model Number	9-ASD-036
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	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 36mm amplatzer septal occluder was chosen for implant using an unknown delivery system.The intracardiac echocardiogram (ie) measurements were performed to determine the size of the device, obtaining a measurement of the defect of 32.6 mm, with a mobile posterior border and a deficient aortic border.During procedure, when the first disc came out, it had a ¿cobra¿ effect.The device was removed and placed in warm solution to recover its original shape and the process was repeated two more times, however it continued to have a cobra effect, so it was decided to place a different device.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 32mm amplatzer septal occluder was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
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.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device assessment could not be performed as the device was not returned for analysis.Field provided three images and three videos showing the cobra deformation.The device batch/lot number was not provided, and therefore the device history record and lot-specific similar complaint could not be reviewed.Based on the available information, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device assessment could not be performed as the device was not returned for analysis.Field provided three images and three videos showing the cobra deformation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Based on the available information, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6)2025, a 36mm amplatzer septal occluder was chosen for implant using a 12f amplatzer torqvue delivery system.The intracardiac echocardiogram (ie) measurements were performed to determine the size of the device, obtaining a measurement of the defect of 32.6 mm, with a mobile posterior border and a deficient aortic border.During procedure, when the first disc came out, it had a ¿cobra¿ effect.The device was removed and placed in warm solution to recover its original shape and the process was repeated two more times, however it continued to have a cobra effect, so it was decided to place a different device.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 32mm amplatzer septal occluder was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
Additional Manufacturer Narrative
An event of device deformity was not confirmed.The device was returned to the lab, and the device met functional specifications.Field provided three images and three videos showing the cobra deformation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 22591932
• Report Number: 2135147-2025-04071
• Device Sequence Number: 9190712
• Product Code: MLV
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 08/10/2026

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-036
• Device Catalogue Number: 9-ASD-036
• Device Lot Number: 9003008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2026
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 02/02/2026; 07/16/2026
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/12/2025; 02/27/2026; 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Weight: 138 LB