MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER OCCLUDER (UNKNOWN); CARDIAC OCCLUSION DEVICE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information was obtained from a 2016 literature article titled, "the ability of percutaneous closure of ventricle-pulmonary connections in the setting of cavopulmonary shunt or after the fontan procedure: our experience." the aim of this study was to study the utility of occluder devices in ventricle pulmonary connections.Material and methods: 5 patients, in the age group 2-19 yrs, were treated percutaneously with occluder devices for ventricle-pulmonary connections.Different types of occluder devices were used: 1 cp cover stent, 1 amplatzer muscular vsd occluder (muscvsd), 2 amplatzer duct occluder ii (adoii), and 1 amplatzer septal occluder (aso).Results: procedural success, with no residual shunt, was achieved in all patients.Although in one case there was a need for implantation of an additional stent and in another case a muscvsd was retrieved and deployed adoii due to its unsatisfactory position.Complications: two patients had thrombus formation in pulmonary trunk proximally to the device.In one case thrombus formation was detected immediately after the procedure and it resolved with warfarin therapy without complications.Second patient, who was lost in follow up for 10 months, was admitted to the hospital with thrombus and cerebral stroke.Summary: percutaneous closure of ventricle-pulmonary connections is technically possible.This intervention should be considered in patients with cavopulmonary shunt or fontan circulation with elevated mpap and volume overload of systematic ventricle.The use of appropriate anticoagulation is crucial for success.

• Brand Name: AMPLATZER OCCLUDER (UNKNOWN)
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 6844483
• MDR Text Key: 84956547
• Report Number: 2135147-2017-00102
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/06/2017

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/06/2017
• 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