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

Catalog Number 9-ASD-028

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Cardiac Arrest (1762); Syncope/Fainting (4411)

Event Date 06/24/2023

Event Type  Death  

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 (b)(6) 2023, a 28mm amplatzer septal occluder was implanted.On (b)(6) 2023, the patient presented to the hospital with syncope.The device was explanted on the same day.It was reported that there was cardiac tissue erosion of the left atrial roof and posterior aorta leading to circulatory collapse.On (b)(6) 2023, the patient passed away due to cardiac erosion.

Event Description

It was reported that on (b)(6) 2023, a 28mm amplatzer septal occluder was chosen for implant.The baseline diameter of the atrial septal defect was 25mm by 23mm, which was measured using transthoracic echocardiography (tte).The baseline measurement of the retro-aortic rim was 5mm.Balloon sizing was not used.During the implant procedure, tte was used.The device was successfully implanted.On (b)(6) 2023, the patient presented to the hospital with syncope.Upon arrival to the hospital, the patient already had one hour of cardiopulmonary resuscitation (cpr).Patient was severely compromised during the event.The device was explanted on the same day to find the cause of symptoms.It was reported that there was cardiac tissue erosion of the left atrial roof and posterior aorta leading to circulatory collapse.On (b)(6) 2023, the patient passed away due to cardiac erosion and multiple organ failure due to prolonged cpr.

Manufacturer Narrative

An event of syncope after ten weeks of implant and patient death one day following the explant procedure was reported.Information from field indicated that the patient presented to the hospital with syncope, already with one hour of cardiopulmonary resuscitation and was severely compromised during the event.The device was explanted to find the cause of symptoms.Intraoperative findings demonstrated erosion of the aso through the dome of the left atrium and posterior wall of the aorta which resulted in circulatory collapse.Information from field indicated that patient death was due to cardiac erosion and multiple organ failure due to prolonged cardiopulmonary resuscitation.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the exact cause of the death following surgery 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): 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: 18467541
• MDR Text Key: 332338619
• Report Number: 2135147-2024-00141
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 8843114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 39 KG