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	03/27/2023
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 9mm amplatzer septal occluder was chosen for implant to treat an atrial septal defect utilizing a 7f amplatzer trevisio intravascular delivery system.The left atrial disc of the occluder did not take the desired shape, it instead had a bulbous shape.The device was removed and a replacement 11mm amplatzer septal occluder was used to complete the procedure successfully.The patient remained hemodynamically stable throughout the procedure.There were no reported adverse patient effects and no clinically significant delay.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device inspection could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that there was no anatomical interference or any angulation or kink in the delivery system upon deployment and an 7f delivery sheath was used.The cause of the reported incident could not be conclusively determined.There is no indication for a product quality issue with regards to manufacture, design, or labeling.D4 - lot #: corrected to 8574129; d4 - catalog #: corrected to 9-asd-009; d4 - expiration date: corrected to 6/30/2027; d4 - udi #: corrected to (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2023, a 9mm amplatzer septal occluder was chosen for implant to treat an atrial septal defect utilizing a 7f amplatzer trevisio intravascular delivery system.The left atrial disc of the occluder did not take the desired shape, it instead had a bulbous shape.There was no interaction with cardiac structures during deployment.There was no angulation or kink noticed in the delivery system.The device was removed and a replacement 11mm amplatzer septal occluder was used to complete the procedure successfully.The patient remained hemodynamically stable throughout the procedure.There were no reported adverse patient effects and no clinically significant delay.

• 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: 16737339
• Report Number: 2135147-2023-01632
• Device Sequence Number: 17820003
• Product Code: MLV
• UDI-Device Identifier: 05415067019172
• UDI-Public: 05415067019172
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/10/2023

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-009
• Device Lot Number: 8574129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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
• Patient Sex: Unknown