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

Catalog Number 9-ASD-032

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

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported that on (b)(6)2024, a 32mm amplatzer septal occluder was chosen for implant, using 12f amplatzer trevisio delivery system.During deployment, the device deformed to a cobra-like shape.There was no angulation or kink noticed in the delivery system.There was no interaction with cardiac structures during deployment.The device was removed.A replacement 32mm amplatzer septal occluder was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Reportedly, it was indicated that there was no anatomical interference, or angulation or kink in the delivery system upon deployment and an 12f delivery system was used.The cause of the reported incident could not be conclusively determined.

• 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: 18743585
• MDR Text Key: 336286241
• Report Number: 2135147-2024-00762
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010236
• UDI-Public: 00811806010236
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-032
• Device Lot Number: 8703333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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
• Treatment: AMPLATZER TREVISIO DELIVERY SYSTEM