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

Model Number CVD0091

Device Problems Migration or Expulsion of Device (1395); Biocompatibility (2886)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 527 patients were implanted with an amplatzer septal occluder and some experienced complications post-procedure.7 patients had cardiac arrhythmia, residual leak, cardiac arrest, or device embolism.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported in a research article that a study was conducted from february 2016 to january 2019 where 527 patients were implanted with an amplatzer septal occluder and some experienced complications post-procedure.7 patients had cardiac arrhythmia, residual leak, cardiac arrest, or device embolism.The embolized device was successfully retrieved and the procedure was completed with another device.The 1 patient who developed heart block after the procedure recovered spontaneously.One of the patients required cardiopulmonary resuscitation during the procedure, and cardiac activity was revived within a minute of cpr.Manufacturer report number: 2135147-2020-00088; 2135147-2020-00082.

• 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: 9781539
• MDR Text Key: 181827652
• Report Number: 2135147-2020-00083
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: NP
• 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: 03/03/2020

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 Model Number: CVD0091
• Device Catalogue Number: CVD0091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/03/2020
• 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): Life Threatening; Other; Required Intervention
• Patient Age: 31 YR