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

Catalog Number	9-ASD-009
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Heart Block (4444); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 9mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using an unknown 7f amplatzer trevisio intravascular delivery system.During the procedure the device took on a cobra shape when opened in the left atrium.The device was removed from the patient and the device was corrected back to its original shape before bring re-inserted into the patient.During implant the device took on a cobra head shape again.This was repeated 2 additional times with the same results.The device was never released from the delivery cable.The device was removed from the patient and replaced with a 10mm amplatzer septal occluder.There were no interactions with cardiac structures.There were no angulations nor kinks noted on the delivery system.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device deformity during deployment and heart block was reported.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.It was indicated that there were no interactions with cardiac structures during deployment and no angulation/kink was observed with the delivery system.The correct size delivery system was used.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Received image appeared to show occluder in cobra deformation.The cause of the reported event could not be conclusively determined.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 9mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using a 7f amplatzer trevisio intravascular delivery system.During the procedure the device took on a cobra shape when opened in the left atrium.The device was removed from the patient and the device was corrected back to its original shape before bring re-inserted into the patient.During implant the device took on a cobra head shape again.This was repeated 1 additional time with the same results.After the second deployment attempt the patient went into heart block.The device was never released from the delivery cable.The device and delivery system were both removed from the patient and the heart block resolved on its own.A new 10mm amplatzer septal occluder and unknown delivery system were used.There were no interactions with cardiac structures.There were no angulations nor kinks noted on the delivery system.

• 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: 20226644
• Report Number: 2135147-2024-04534
• Device Sequence Number: 7240158
• Product Code: MLV
• UDI-Device Identifier: 00811806010069
• UDI-Public: (01)00811806010069(17)271031(10)8776554
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 10/18/2024

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-009
• Device Lot Number: 8776554
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• 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: 7F AMPL TREV DS [9-ATV07F45/80 LOT: 10020307]
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 16 KG