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

Catalog Number	9-ASD-006
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	08/09/2024
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 (b)(6) 2024, after the laa was closed via atrial septal punctured approach, there was right to left shunt flow occurring which started to decline the blood oxygen saturation (spo2).An iatrogenic atrial septal defect (iasd) was diagnosed.A 6mm amplatzer septal occluder (aso) was attempted for closure of the iasd.However, the occluder deformed into the cobra-head shaped.The device wasn't released from the delivery cable.There was no interaction with cardiac structures or angulation/kink in the delivery system.The device was replaced with a 7mm aso to resolve the event.The procedure was completed without any issue and spo2 returned to normal level.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2024, after the laa was closed via atrial septal punctured approach, there was right to left shunt flow occurring which started to decline the blood oxygen saturation (spo2).An iatrogenic atrial septal defect (iasd) was diagnosed.A 6mm amplatzer septal occluder (aso) was attempted for closure of the iasd.However, the occluder deformed into the cobra-head shaped.The device wasn't released from the delivery cable.There was no interaction with cardiac structures or angulation/kink in the delivery system.The device was replaced with a 7mm aso to resolve the event.The procedure was completed without any issue and spo2 returned to normal level.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.
Additional Manufacturer Narrative
An event of device deformity during procedure was reported.A returned device assessment could not be performed as the device was not returned for analysis.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.A 8f sheath was used to deliver the device.Please note that per the instructions for use, the recommended size delivery system for use with a 8 mm amplatzer septal occluder is an 6f.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 20130924
• Report Number: 2135147-2024-04333
• Device Sequence Number: 3227184
• Product Code: MLV
• UDI-Device Identifier: 00811806010038
• UDI-Public: (01)00811806010038(17)241031(10)7262685
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/23/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 9-ASD-006
• Device Lot Number: 7262685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2019
• 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 Age: 80 YR
• Patient Sex: Unknown