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

Model Number SEPTAL OCCLUDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tachycardia (2095)

Event Date 01/01/2023

Event Type  Injury  

Event Description

The article, "abstracting journal of the medical conference for japanese society of congenital interventional cardiology (jcic) vol.33" was reviewed.It was reported that on an unknown date, an 18mm amplatzer septal occluder was selected for implantation using an unknown 9f delivery sheath.Prior to procedure it was noted that the patient had been hospitalized due to the patient's being unable to walk and an abnormal electrocardiogram.Echocardiography had revealed an aneurysm of the left ventricular apex.The ventricle wall had thinned and ventricular septum perforation (vsp) was noted.The vsp had the following dimensions, 17 x 11 mm on day 2 of hospitalization.On day 5 of hospitalization the patient's respiratory status was worsened and was managed by intratracheal intubation and intra-aortic balloon pump was applied.Coronary angiography confirmed that there was no apparent lesion except left anterior descending artery for total occlusion, but did not require percutaneous intervention.Extracorporeal membrane oxygenation (ecmo) was attached via the patient's femoral vein.It was noted that due to the transesophageal echocardiography probe being unable to cross over the cardiac portion of the esophagus, that sizing of a amplatzer septal occluder proved difficult.It was noted during procedure that the right atrial disc of the 18mm amplatzer septal occluder became deformed when being deployed.The decision was made to gently push the 9f delivery sheath against the right atrial disc in an attempt to reconfigure it.The occluder was successfully implanted as intended and with no configuration problems.However, it was noted that the patient suffered from ventricular tachycardia several times throughout the procedure and required a defibrillator to manage the patient's heart rhythm.The patient remained hemodynamically stable throughout the procedure with management of ecmo.No additional information was provided.The primary author of the article is yusuke nakano, md.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Event date is unknown and estimated.

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer septal occluder implant were reported in a research article in a patient with multiple co-morbidities including diabetes and hypertension.Some of the complications reported were aneurysm, ventricle wall thinned, ventricular septum perforation, respiratory and ventricular tachycardia due to severe hemodynamic status these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 16607658
• MDR Text Key: 311956160
• Report Number: 2135147-2023-01328
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: 00811806010151
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 88 YR
• Patient Sex: Male