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

Model Number	9-ASD-022
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	10/08/2022
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) 2022, a 22mm amplatzer septal occluder was selected for an implant using a 10f amplatzer torqvue delivery system(itv).Cobra deformation was noted while deploying the occluder.Device was removed from the patient prior to release from the delivery cable.There was no interaction with the cardiac structures during deployment and no angulation or kink noticed in the delivery system it is unknown if there was a replacement device implanted.The patient remain hemodynamically stable throughout the procedure.No patient consequences were reported.
Additional Manufacturer Narrative
An event of device deformation was reported.The device was returned to abbott for investigation and 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.Based on the information received, the cause of the reported event could not be conclusively determined but may have due to the use of a larger delivery system.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note per the instructions for use, the recommended size delivery system for a 22mm amplatzer septal occluder is a 9f delivery system.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: it was reported that a second 24mm amplatzer septal occluder was used during the procedure.During the procedure, the tip of the device was curving and forming like a cobra.Both devices were removed from the patient prior to release from the delivery cable.

• 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: 15669542
• Report Number: 2135147-2022-01785
• Device Sequence Number: 15040087
• Product Code: MLV
• UDI-Device Identifier: 05415067019295
• UDI-Public: 05415067019295
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/16/2023

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-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 8331229
• 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: 10/08/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• 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