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

Model Number 9-ASD-012

Device Problem Biocompatibility (2886)

Patient Problems Chest Pain (1776); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient was implanted with a 12mm amplatzer septal occluder.Three months post-procedure, an event of chest pain, pericardial effusion, and device explant was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "perforation of the atrial wall and aortic sinus after closure of an atrial septal defect with an atriasept occluder: a case report", was reviewed.This research article presents a case study on a (b)(6)-year-old boy with a history of chest tightness who presented with perforation of the atrial wall and aortic sinus after closure of an atrial septal defect.The patient underwent cardiac catheterization and device closure with an amplatzer septal occluder.Balloon sizing was performed under fluoroscopic and transthoracic echocardiography (tte) guidance.The atrial septal defect(asd) measured 6 mm, and accordingly, a 12mm amplatzer septal occluder device was selected and deployed successfully across the defect by the conventional technique.After confirmation of the position and stability of the device on fluoroscopy and tte, it was released.No short-term complications occurred, and further follow-up remained uneventful.Three months post-procedure, the patient suddenly developed chest pain that could not be relieved.Emergency echocardiography was performed immediately and showed a large amount of pericardial effusion.Cardiac computerized tomography(ct) showed changes after transcatheter closure of the atrial septal defect and moderate pericardial effusion.The patient, in shock, underwent urgent operation.Intra-operative examination revealed that the size of the heart was normal, a large amount of bloody effusion was found in the pericardium, about 1-2 mm crevasse was seen in the right atrium roof and noncoronary aortic sinus, and the occluder was well fixed, without displacement or falling off at the atrial septum.A temporary pledgeted suture was placed on the ruptured noncoronary sinus of the ascending aorta to stop the bleeding through a very small perforation.After standard bicaval cannulation, cardiopulmonary bypass was initiated.The right atrium was opened after aortic cross clamping and antegrade delivery of blood cardioplegia.The amplatzer septal occluder was then removed, and a temporary autologous pericardial patch was constructed for the ostial secundum asd.Finally, the right atrial and noncoronary aortic sinus walls were primarily repaired.The patient was discharged on the 12th postoperative day in good overall condition.Color doppler ultrasound showed no pericardial effusion or shunt at the atrial level postoperatively.The article concluded that although percutaneous closure of asd is regarded as a routine procedure, we should not forget the potentially lethal complications, especially cardiac erosion.Therefore, we should carefully evaluate the risk of erosion before surgery, and careful lifelong follow-up is needed.The primary author of the article is zai-qiang zhang, department of cardiology, the first college of clinical medical sciences, china three gorges university, 183 yiling road, yichang, hubei province 443000, people¿s republic of china.The correspondence author of the article is jia-wang ding, department of cardiology, the first college of clinical medical sciences, china three gorges university, 183 yiling road, yichang, hubei province 443000, people¿s republic of china with the corresponding email: dingjiawang@163.Com patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11829015
• MDR Text Key: 250811684
• Report Number: 2135147-2021-00170
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-012
• Device Catalogue Number: 9-ASD-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR