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

Catalog Number 9-ASD-010

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that a 10mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using an unknown abbott delivery system.During implant the device took on a cobra shape.The device was removed from the patient and replaced with a new 10mm amplatzer septal occluder.There were no interactions with cardiac structures.There were no angulations or kinks noted in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.

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.Imaging was received from the field appearing to show the device presenting cobra deformation within the body.However, it could not be confirmed as there was no cobra shape 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 defined manufacturing specifications.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: 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: 18759967
• MDR Text Key: 336012804
• Report Number: 2135147-2024-00826
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010076
• UDI-Public: 00811806010076
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 9012442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1