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

Model Number 9-ASD-008

Device Problems Difficult to Insert (1316); Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 12/18/2013

Event Type  Injury  

Event Description

An 8mm amplatzer septal occluder (aso) was attempted in an 8mm ventricular septal defect (vsd) of a patient with a complex medical history including av valve reconstruction, chronic atrial fibrillation and the formation of a cardiac septum.; however, that same day the aso embolized into a branch of the left pulmonary artery (pa) and could not be retrieved as the catheter could not be inserted through the pa.A 14mm aso was then attempted in the same vsd but the device pushed through the defect during the push-pull maneuver and was removed and the vsd was surgically repaired.The embolized 8mm aso posed no obstruction and remains in the pa.

Manufacturer Narrative

The results of this investigation are inconclusive because the product was not returned for analysis; however, review of the device history record confirmed the product met manufacturing requirements prior to shipment.The cause of the reported event remains unknown.

• 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: 3635154
• MDR Text Key: 3984657
• Report Number: 2135147-2014-00015
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: 9-ASD-008
• Device Lot Number: 4262437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2013
• 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): Other
• Patient Age: 18 YR
• Patient Weight: 32