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

Model Number 9-ASD-008

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Rupture (2208); Injury (2348)

Event Date 02/25/2014

Event Type  Injury  

Event Description

The patient had a ruptured, sub-valvular, membranous ventricular septal defect post-infarct.During the procedure, three devices were attempted: 8mm and 10mm amplatzer septal occluders (aso) and a 25mm amplatzer pfo occluder (pfo).First, the 8mm aso embolized into the right pulmonary artery.Next, a 10mm aso and the pfo were attempted, were found to be mis-sized and retrieved.After closing the apex, the patient started hemorrhaging into the pericardium which was most likely due to the injury to the right ventricle where the wall thickness was reduced by the infarct.The patient died during the procedure due to circulatory collapse.The devices were not suspected to have contributed to the patient's death.

Manufacturer Narrative

The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.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: 3686151
• MDR Text Key: 4297032
• Report Number: 2135147-2014-00023
• 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: 02/27/2014

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: Physician
• Device Expiration Date: 05/16/2017
• Device Model Number: 9-ASD-008
• Device Lot Number: 1205162562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2012
• 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): Death; Hospitalization
• Patient Age: 75 YR