MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCC 22MM PKG STER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-022

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Embolism (1829); Chest Tightness/Pressure (2463); Palpitations (2467)

Event Type  Injury  

Event Description

According to the article, "management of a large atrial septal occluder embolized to the left ventricular outflow tract without the use of cardiac surgery," the patient's defect measured 24mm via sizing balloon and a 22mm amplatzer septal occluder (aso) was implanted and optimal positioning was confirmed.The next morning, the patient complained of acute chest discomfort and palpitations.A trans-thoracic echo confirmed the aso had embolized to the left ventricular outflow tract.The patient was brought back to the cath lab where the aso was percutaneously retrieved.A 28mm aso was implanted.Loh, joshua p.Et al, management of a large atrial septal occluder embolized to the left ventricular outflow tract without the use of cardiac surgery, catheterization and cardiovascular interventions, doi: 10.1002/ccd/84:497-502 (2014).

Manufacturer Narrative

The results of this investigation are inconclusive because the product was not returned for analysis and the lot number was not provided which prevented sjm from reviewing the device history record.The cause of the reported event remains unknown.

• Brand Name: AMPLATZER SEPTAL OCC 22MM PKG STER
• 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: 4089678
• MDR Text Key: 4828025
• Report Number: 2135147-2014-00084
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• 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 Age: 31 YR