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

Model Number	9-ASD-028
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	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 28 mm amplatzer septal occluder was selected for implant.During the procedure, the device presented in a cobra deformation.There was no angulation of kinks in the ds or interaction with any cardiac structures.The device was replaced with a 30 mm amplatzer septal occluder to resolve the event.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.
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.
Additional Manufacturer Narrative
An event of device deformity was not confirmed via returned device analysis.The device was returned to abbott for investigation and the device met functional specifications when analyzed 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the cause of the reported device deformity could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on 17 mar.2025, a 28mm amplatzer septal occluder was selected for implant.During the procedure, the device presented in a cobra deformation.There was no angulation of kinks in the ds or interaction with any cardiac structures.The device was replaced with a 30mm amplatzer septal occluder to resolve the event.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.

• 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: 21827693
• Report Number: 2135147-2025-01917
• Device Sequence Number: 9253918
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: (01)00811806010212(17)280731(10)9203616
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/05/2025

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-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 9203616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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 Sex: Unknown