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

Model Number	9-ASD-019
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	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 19mm amplatzer septal occluder was chosen for implant using a 9f non-abbott sheath.During procedure, the physician noticed that the desired shape was not taken by the device and had a cobra deformation, that¿s why they have to retrieve the device back.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.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.No additional information was provided.
Additional Manufacturer Narrative
Na 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.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported device deformity could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: type of investigation: 4118 type of investigation not yet determined; investigation findings: investigation conclusions: 11 conclusion not yet available.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device deformity was reported.The investigation found that the patch inside the distal disc had a torn.Despite the damage noted on the device, the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including verification of torn patch.Therefore, there is no evidence to indicate that the reported unit was defective prior to shipment.The cause of the reported device deformity could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 21559732
• Report Number: 2135147-2025-01191
• Device Sequence Number: 4373534
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: (01)00811806010168(17)281231(10)10167697
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 06/12/2025

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-019
• Device Catalogue Number: 9-ASD-019
• Device Lot Number: 10167697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 05/21/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/15/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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