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

Model 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	02/20/2023
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, an 8mm amplatzer septal occluder was chosen for implant with an 8f amplatzer torqvue delivery system.During deployment, the device had a cobra deformation.A decision was made to replace the device with a 10mm amplatzer septal occluder but the replacement device also had a cobra deformation.It was then decided to remove the replacement device and abort the procedure.The deformed device was never released from the delivery cable while inside the patient.It was reported there was interaction with cardiac structures during deployment.There was no report of any angulation/kink noticed in the delivery system.There was no report of any adverse patient consequences.The patient remained hemodynamically stable throughout the procedure and the patient status was reported as stable.No additional information was provided.
Additional Manufacturer Narrative
An event of device deformity was reported.The investigation confirmed 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 specifications.The cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, as recommended size delivery system for use with a 8 mm amplatzer septal occluder is an 6-7f.

• 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): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16537262
• Report Number: 2135147-2023-01172
• Device Sequence Number: 6389338
• Product Code: MLV
• UDI-Device Identifier: 05415067019165
• UDI-Public: 05415067019165
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/21/2023

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: 9-ASD-008
• Device Catalogue Number: 9-ASD-008
• Device Lot Number: 8281313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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: AMPLATZER TORQVUE DS, 9-ITV08F45/80.
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 20 KG