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

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problems Erosion (1750); Chest Pain (1776); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "atrio-aortic erosion caused by amplatzer atrial septal occluder ¿ a case report", was reviewed.The following article reports a case study on a (b)(6)-year-old man who presented sometime between december 2017 to march 2018 with late complications 1-year after interventional treatment of an atrial septal defect using an amplatzer septal occluder.The patient presented with sudden-onset chest pain, weakness and confusion.Clinical examination revealed, alongside hypotension and tachycardia, cold and clammy extremities.Cardiac tamponade with dense pericardial effusion was revealed in the transthoracic echocardiography.Emergency sternotomy due to cardiac tamponade with hemodynamic instability remained the only option.After full sternotomy a bleeding from the bottom of the aortic root was revealed.Erosions between the left atrial roof and the noncoronary aortic sinus have been discovered as being the source of the bloody pericardial effusion.The atrial septal occluder was removed from the patient and the remaining septal defects were closed using bovine pericardium.The perforated areas of the left atrium and the aortic sinus were closed by direct running suture.The postoperative evolution showed no neurological or other major complications.The patient fully recovered and was discharged nine days after surgery.Six months after surgery there were no signs of heart failure and the patient had an almost normal physical resilience.Transthoracic echocardiography showed normal right- and left-heart function with no signs of residual shunts.The article concluded that atrio-aortic erosion after percutaneous closure of atrial septal defects is a surgical emergency complicated by the absence of specific symptoms and indices.The only reliable diagnostic method remains the diagnostic sternotomy, which should be launched with out delay, taking into account the patient¿s medical history.The primary and correspondence author of the article is christine e.Kamla, department of cardiac surgery, lmu university hospital, marchioninistrasse 15, 81377 munich, germany with the corresponding email christine.Kamla@med.Uni-muenchen.De.

Manufacturer Narrative

As reported in a research article, a patient had erosion between the left atrial roof and the noncoronary aortic sinus one ear after device implant, so the device was explanted.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.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11807688
• MDR Text Key: 250061768
• Report Number: 2135147-2021-00182
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR