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

Model Number	SEPTAL OCCLUDER
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	05/09/2023
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) 2023, a 12mm amplatzer septal occluder was chosen for implant using a 9f amplatzer trevisio intravascular delivery system.During deployment of the left atrial disc, it was noticed the device had a bulbous deformation.The deformed device was never released from the delivery cable while inside the patient.The device would not return to the original proper shape and a decision was made to replace the device with a new 12mm amplatzer septal occluder.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 replacement 12mm amplatzer septal occluder was successfully implanted.The patient status was reported as stable.
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 defined manufacturing specifications.Information from the field indicated that there was no anatomical interference, there was no angulation or kink in the delivery system upon deployment, and an 9f delivery system was used.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 regards 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 ; 6517565400
• MDR Report Key: 17035453
• Report Number: 2135147-2023-02383
• Device Sequence Number: 6393589
• Product Code: MLV
• UDI-Device Identifier: 00811806010090
• UDI-Public: 00811806010090
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/27/2023

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: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 8616762
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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-ATV09F45/80
• Patient Age: 56 YR
• Patient Sex: Male