MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-020

Device Problem Biocompatibility (2886)

Patient Problems Chest Pain (1776); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported through a research article identifying amplatzer septal occluder that may be related to a pericardial effusion, with cardiac tamponade.Specific patient information is documented as unknown.Details are listed in the attached article, titled aortic wall erosion 4 years after amplatzer septal occluder implantation.A 20 mm amplatzer septal occluder was implanted in a (b)(6) patient after a stroke event successfully.4 years later the patient presented to the emergency room with chest pain.A transesophageal echocardiogram (tte) was performed and an pericardial effusion was seen and cardiac tamponade with early diastolic collapse of the right atrium and ventricle.The patient arrested on admission and was transferred to the operating room.A pericardiotomy was performed.When the tamponade was released, the heart recovered to sinus rhythm.Blood cots were removed and a hemorrhage was noted.Cardiopulmonary bypass was performed to repair the aortic noncoronary sinus erosion.The 20 mm aortic erosion was repaired used 2 pericardial patches without removing the amplatzer.The patient was reported to be stable post procedure and was discharged.

Manufacturer Narrative

Additional information: as reported in a research article, erosion, pericardial effusion and tamponade occurred four years after amplatzer septal occluder implant.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): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10065358
• MDR Text Key: 191256370
• Report Number: 2135147-2020-00213
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR