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

Model Number 9-ASD-026

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Dyspnea (1816); Brain Injury (2219); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 10/14/2019

Event Type  Death  

Event Description

On (b)(6) 2019, a 26 mm amplatzer septal occluder was successfully implanted.The patient had two atrial septal defects, but the user elected to close one.The postoperative examination was unremarkable and the patient was discharged.Two days later, on (b)(6) 2019, the patient presented to the emergency department with complaints of dypsnea and chest pain.The patient was hypotensive, iv fluids were administered and an echocardiogram confirmed a cardiac tamponade.The patient was transferred to the catheter laboratory for a perdicardial drain and suffered cardiac arrest.A pericardiocentesis was performed removing 600 ml of fluid.Spontaneous circulation returned after 12 minutes and the patient was transferred to the intensive care unit (icu) intubated and ventilated.The patient didn't wake in the icu.A ct scan was performed revealing hypoxic ischemic encephelopathy.Active care was withdrawn and the patient died.The autopsy concluded the patient died due to cerebral hypoxia caused by right atrial perforation following insertion of the occluder.

Manufacturer Narrative

An event of right atrial perforation, effusion, tamponade and patient death was reported.The results of the investigation are inconclusive since 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 at the time of commercialization.An autopsy was performed, which concluded the cause of death was cerebral hypoxia following a cardiac arrest due to an erosion caused perforation at the 'upper edge' of the device.Based on the information received, the root cause of the erosion could not be conclusively determined.Per the instructions for use, (b)(4) ver.A, "physicians should be aware of the risk of erosion.Erosion may be the result a complex set of interactions between factors including, but not limited to the underlying anatomic substrate, retro-aortic rim of less than 5mm in any echocardiographic plane, and the dynamic hemodynamic counter-motion between the atrium and the aorta.However, there is insufficient data including inadequate echocardiographic information about the cases already reported to determine etiology of erosion.".

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9380337
• MDR Text Key: 168173550
• Report Number: 2135147-2019-00416
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: 00811806010205
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

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
• Device Expiration Date: 09/30/2022
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 6167499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• 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; Required Intervention