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

Catalog Number	9-ASD-008
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	10/23/2024
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 a 8mm amplatzer septal occluder was selected for implant on 23 october 2024 using a 7f amplatzer trevisio intravascular delivery system to treat an atrial septal defect (asd).During implant the device took on a cobra head shape.The device was removed from the patient.The device was re-deployed outside of the patient and the device was conformed back to its original shape.The device was re-inserted and deployed once more, however the left atrial disc formed a cobra head shape while in the left atrium.The delivery sheath was re-positioned from the atrial septal defect to the right atrium.The device was deployed once more but the left atrial disc formed a cobra head shape.The device was not released from the delivery cable.The device was removed from the patient and replaced with a new 8mm amplatzer septal occluder using the same delivery system.There was some interaction with cardiac structures.There were no angulations or kinks noted on the delivery system.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity was reported.Information from field indicated that there was some interaction with cardiac structures and that there were no angulations or kinks noted on the delivery system.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.Per the instructions for use, artmt600157386 revision b table t1 the recommended size delivery system for use with a 8 mm septal occluder is an 6f.A 7f sheath was used to deliver the device.The cause of the reported incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.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 a 8mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using a 7f amplatzer trevisio intravascular delivery system to treat an atrial septal defect (asd).During implant the device took on a cobra head shape.The device was removed from the patient.The device was re-deployed outside of the patient and the device was conformed back to its original shape.The device was re-inserted and deployed once more, however the left atrial disc formed a cobra head shape while in the left atrium.The delivery sheath was re-positioned from the atrial septal defect to the right atrium.The device was deployed once more but the left atrial disc formed a cobra head shape.The device was not released from the delivery cable.The device was removed from the patient and replaced with a new 8mm amplatzer septal occluder using the same delivery system.There was some interaction with cardiac structures.There were no angulations or kinks noted on the delivery system.There were no adverse effects to the patient.The patient status was 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: 20695940
• Report Number: 2135147-2024-05802
• Device Sequence Number: 15075356
• Product Code: MLV
• UDI-Device Identifier: 00811806010052
• UDI-Public: (01)00811806010052(17)280229(10)8942154
• 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): 12/27/2024

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-008
• Device Lot Number: 8942154
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2023
• 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: 7F AMPL TREV DS [9-ATV07F45/80, LOT: 10351255]
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 43 KG