MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-018

Device Problem Decrease in Pressure (1490)

Patient Problems High Blood Pressure/ Hypertension (1908); Device Embedded In Tissue or Plaque (3165)

Event Date 01/26/2016

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 batch number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2016, an 18mm amplatzer septal occluder (aso) was implanted after balloon-sizing.Post-implant, the patient experienced worsening pulmonary hypertension secondary to the closure of the asd and an echo confirmed a residual inferior shunt around the occluder.On (b)(6) 2016, the aso was explanted and there was a drop in pa pressure (70mmhg) and an increase in systemic saturation (92%).Post asd closure, the patient was nyha class iv and upon explant of the aso, the patient was reclassified as nyha class ii-iii.The patient is in stable condition and no future attempts to close the asd will occur.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• 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 ; 6517564470
• MDR Report Key: 5431668
• MDR Text Key: 38077834
• Report Number: 2135147-2016-00014
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• 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): Required Intervention
• Patient Age: 49 YR