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

Catalog 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	11/14/2024
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 14 november 2024, a 28mm amplatzer septal occluder was chosen to close an atrial septal defect (asd) using a 10f amplatzer trevisio intravascular delivery system.The device was prepared by the physician and loaded into the delivery system.Before the delivery system was inserted into the patient, the device could safely exit the loader and was then reinserted into the loader.Once the device was inside the patient, the left disc was deployed in the left atrium and the right disc was released in the right atrium.The positioning was not satisfactory, so the device was recaptured twice.Once the left disc was deployed again, it opened with the distal nose portion towards the waist, almost resembling a flower shape.When the device was attempted to be recaptured, the device would not recapture into the sheath.The device was mostly recaptured but not entirely.A wire was used to remove the sheath and the device from the patient.There was no interaction with cardiac structures during deployment.There was no angulation or kink noted in the delivery system.The devices were replaced with a new 28mm amplatzer septal occluder and 10f amplatzer trevisio intravascular delivery system, and the procedure was completed successfully.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was discharged.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.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 did not indicate a lot-specific product issue.Based on the information received and returned device analysis, 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 (b)(6) 2024, a 28mm amplatzer septal occluder was chosen to close an atrial septal defect (asd) using a 10f amplatzer trevisio intravascular delivery system.The device was prepared by the physician and loaded into the delivery system.Before the delivery system was inserted into the patient, the device could safely exit the loader and was then reinserted into the loader.Once the device was inside the patient, the left disc was deployed in the left atrium and the right disc was released in the right atrium.The positioning was not satisfactory, so the device was recaptured twice.Once the left disc was deployed again, it opened with the distal nose portion towards the waist, almost resembling a flower shape.When the device was attempted to be recaptured, the device would not recapture into the sheath.The device was mostly recaptured but not entirely.A wire was used to remove the sheath and the device from the patient.There was no interaction with cardiac structures during deployment.There was no angulation or kink noted in the delivery system.The devices were replaced with a new 28mm amplatzer septal occluder and 10f amplatzer trevisio intravascular delivery system, and the procedure was completed successfully.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was discharged.

• 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: 20925398
• Report Number: 2135147-2024-06346
• Device Sequence Number: 5105723
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: (01)00811806010212(17)281031(10)10075358
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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 Catalogue Number: 9-ASD-028
• Device Lot Number: 10075358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV10F45/80
• Patient Sex: Unknown