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

Catalog Number	9-ASD-018
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	02/12/2024
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.Na.
Event or Problem Description
It was reported that on (b)(6) 2024, a 18mm amplatzer septal occluder was chosen for implant using an 10f non-abbott delivery sheath.During deployment, the physician noticed that the device was not taking the desired shape and had a cobra deformation.The deformed device was never released from the delivery cable while inside the patient and the device got retrieved.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 procedure got aborted.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 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.Reportedly, it was indicated that there was no anatomical interference, there was no angulation or kink in the delivery system upon deployment, and an 10f delivery sheath was used.As recommended per the instructions for use for 18 mm amplatzer ¿ septal occluder the 8f was intended use which could have contributed to the reported event of deformity.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2024, a 18mm amplatzer septal occluder was chosen for implant using an 10f non-abbott delivery sheath.During deployment, the physician noticed that the device was not taking the desired shape and had a cobra deformation.The deformed device was never released from the delivery cable while inside the patient and the device got retrieved.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 procedure got aborted.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.

• 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: 18841271
• Report Number: 2135147-2024-01007
• Device Sequence Number: 12566355
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: (01)00811806010151(17)280229(10)8951800
• 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: 2024
• Device Explanted Year: 2024
• 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): 04/12/2024

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-018
• Device Lot Number: 8951800
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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