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

Model Number 9-ASD-020

Device Problem Material Deformation (2976)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 05/13/2014

Event Type  Injury  

Event Description

A 20mm amplatzer septal occluder (aso) and a 10f amplatzer torqvue 45 delivery system (dtv45) were selected for used but the aso deployed cobra-shaped in the patient.The physician paused to see if the aso would go back to its normal shape but the deformation persisted.Another 20mm aso was deployed multiple times in the patient's heart with the same dtv45.Sheath position and device configuration could not be obtained.The patient became hypotensive and a transthoracic echocardiogram diagnosed cardiac tamponade.Pericardiocentesis was performed followed by surgical intervention where the perforation was repaired and the atrial septal defect was closed with a patch.The patient was recovering well after the procedure.The physician believes that the perforation was caused by the repeated attempts to deploy the second aso but was not sure if it was the aso or delivery system that was the cause.Mdr 2135147-2014-00050 for the amplatzer torqvue delivery system.

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.Review of the device history record confirmed this lot met manufacturing requirements prior to shipment.The cause for the reported event remains unknown.

Manufacturer Narrative

This event was reviewed by the st.Jude medical erosion board and confirmed that no 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: 3825013
• MDR Text Key: 4402389
• Report Number: 2135147-2014-00049
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 4422746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• 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): Required Intervention