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

Model Number 9-ASD-019

Device Problems Premature Activation (1484); Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Cardiac Perforation (2513)

Event Date 07/10/2014

Event Type  Injury  

Event Description

A 19mm amplatzer septal occluder (aso) was deployed in the defect and still attached to the delivery cable while a trans-esophageal echo (tee) was performed; however, the tee could not identify the aso's edge at the aortic rim as the image was blurry.An intra-cardiac echo was performed instead and the aso was detached from the cable.The postoperative course was uneventful.The next morning the patient went into shock.Pericardiocentesis was performed but did not alleviate the patient's blood pressure so the patient underwent open-heart surgery.During surgery, a perforation was observed at the aortic rim and into the cardiac muscle leading to tamponade.The aso was explanted and the perforation and atrial septal defect were surgically repaired.The physician was unsure what caused the perforation.The patient is recovering well.

Manufacturer Narrative

(b)(4).The device was not returned to sjm for analysis.A review of the device history record confirmed the product met manufacturing requirements prior to shipment.The results of this investigation are inconclusive because the product was not returned for analysis.This event was reviewed by the st.Jude medical erosion board who confirmed that erosion occurred.

• 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 ; 6517565400
• MDR Report Key: 3955915
• MDR Text Key: 15363604
• Report Number: 2135147-2014-00072
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 9-ASD-019
• Device Lot Number: 4178602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2013
• 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): Required Intervention