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

Catalog Number 9-ASD-024

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

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

It was reported that a 24 mm amplatzer septal occluder was selected for implant on (b)(6) 2023 using a 9f amplatzer trevisio intravascular delivery system.During implant the device took on a cobra shape.It was noted that the device was replaced with a new 22 mm amplatzer septal occluder, which was successfully implanted.There were no angulations or kinks noted in the delivery system.It was noted that the first 24 mm amplatzer septal occluder remained in the cobra shape when deployed in a bowl with saline.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure and there were no adverse effects to the patient.

Manufacturer Narrative

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

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.Three images were received from the field, which appeared to show an occluder partially and then fully deployed in a cobra conformation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Possible causes of device deformity include use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment.The correct delivery system was used and no anatomical interference, or angulation or kink in the delivery system was noted.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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): 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: 18120846
• MDR Text Key: 328280674
• Report Number: 2135147-2023-04987
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010199
• UDI-Public: 00811806010199
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 8716468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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