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

Model Number	SEPTAL OCCLUDER
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	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 7mm amplatzer septal occluder was selected for an implant.During the procedure, the occluder presents a cobra deformation.The physicians removed the device from the patient, "massaged" it in solution and reload it one more time.The second attempt has the same issue.The was no interaction with cardiac structures during deployment and no angulation or kink noticed in the delivery system.The physician replaced the device with a 9mm amplatzer septal occluder amplatzer that completed the procedure.The patient is 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 could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Additionally, a video was received from the field and it appears to show the device deformity during procedure.However, it could not be confirmed as there was no shape of device deformity during the returned device analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.Information from the field indicated that there was no anatomical interference, or any angulation or kink in the delivery system upon deployment and an 9f delivery system was used.Based on the information available, the cause of the reported incident appears to be related to procedure circumstances.Per the instructions for use, the minimum recommended the sheath size delivery system for use with a 7mm amplatzer septal occluder is an 6f.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device inspection could not be performed as the device was not returned for analysis.Additionally, a video was received from the field and it appears to show the device deformity during procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.Information from the field indicated that there was no anatomical interference, or any angulation or kink in the delivery system upon deployment and an 9f delivery system was used.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication for a product quality issue with regards to manufacture, design, or labeling.

• 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; ave. 2 el coyol; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16936756
• Report Number: 2135147-2023-02120
• Device Sequence Number: 20289172
• Product Code: MLV
• UDI-Device Identifier: 00811806010045
• UDI-Public: 00811806010045
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 08/29/2023

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 Expiration Date: 09/30/2025
• Device Model Number: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-007
• Device Lot Number: 7715990
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 08/10/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 05/24/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2020
• 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¿ 45° DELIVERY SYSTEM. 9-ITV09F4
• Patient Sex: Male