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

Model Number 9-ASD-030

Device Problem Partial Blockage (1065)

Patient Problems Embolism (1829); Tricuspid Regurgitation (2112); Ventricular Tachycardia (2132)

Event Date 12/02/2014

Event Type  Injury  

Event Description

After a 30mm amplatzer septal occluder (aso) was deployed, the patient went into ventricular tachycardia and required a single defibrillation to return to normal sinus rhythm.Fluoroscopy confirmed the aso had embolized superior to the pulmonic valve.Multiple attempts were required before the aso was finally snared.The percutaneous removal of the aso resulted in a larger atrial septal defect and the onset of severe tricuspid regurgitation.Surgical intervention was required.

Manufacturer Narrative

(b)(4).The results of this investigation are inconclusive because the aso was not returned for evaluation.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for 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: 4820311
• MDR Text Key: 5895866
• Report Number: 2135147-2015-00061
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 4797078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2014
• 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