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

Model Number 9-ASD-028

Device Problem Poor Visibility (4072)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on 26 january 2023, a 28mm amplatzer septal occluder was selected for implant using a 10f amplatzer torqvue delivery sheath.It was noted during procedure that when removing the dilator and guidewire visibility of the delivery sheath was lost on the transesophageal echocardiogram (tee).However, fluoroscopy was used to obtain visibility.It was noted that the left atrial disc of the 28mm amplatzer septal occluder had been deployed, but there was still no visibility noted on the tee.It was noted at this point that the patient had began to develop a pericardial effusion.The decision was made to fully remove the 28mm amplatzer septal occluder and the 10f amplatzer torqvue delivery sheath and aborted the implant procedure.A pericardiocentesis was then performed to drain the patient's pericardial effusion.The patient was then emergently sent to surgery to address a wound sustained to the patient's roof of the left atrium.It was reported that the patient had been removed from extracorporeal circulation and was in stable condition at the time of report.There are no allegations of malfunction against either the occluder or the delivery sheath.

Manufacturer Narrative

An event of pericardial effusion was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on (b)(6) 2023, a 28mm amplatzer septal occluder was selected for implant using a 10f amplatzer torqvue delivery sheath.It was noted during procedure that when removing the dilator and guidewire visibility of the delivery sheath was lost on the transesophageal echocardiogram (tee).However, fluoroscopy was used to obtain visibility.It was noted that the left atrial disc of the 28mm amplatzer septal occluder had been deployed, but there was still no visibility noted on the tee.It was noted at this point that the patient had began to develop a pericardial effusion.The decision was made to fully remove the 28mm amplatzer septal occluder and the 10f amplatzer torqvue delivery sheath and aborted the implant procedure.A pericardiocentesis was then performed to drain the patient's pericardial effusion.The patient was then emergently sent to surgery to address a wound sustained to the patient's roof of the left atrium.It was reported that the patient had been removed from extracorporeal circulation and was in stable condition at the time of report.There are no allegations of malfunction against either the occluder or the delivery sheath.

• 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: 16315888
• MDR Text Key: 309013840
• Report Number: 2135147-2023-00423
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019325
• UDI-Public: 05415067019325
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 7942563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2021
• 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
• Patient Outcome(s): Required Intervention; Life Threatening