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

Model Number 9-ASD-032

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Endocarditis (1834); Staphylococcus Aureus (2058); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.Note, this mdr was originally reported under mfr report # 2135147-2015-00105 but due to a technical issue, i was advised to void it and repackage the submission.Mfr report # 2135147-2015-00110 is intended to replace mfr report # 2135147-2015-00105.

Event Description

According to the article "late bacterial endocarditis of an amplatzer atrial septal defect occluder device" (doi 10.1016/j.Amjcard.2009.09.011), a (b)(6) male with a large secundum atrial septal defect (asd) was implanted with a 32mm amplatzer septal occluder (aso).Approximately 2.5 years after implant, the patient presented with a week-long history of fever.A urinalysis revealed staphylococcus aureus bacteremia.A transesophageal echocardiography revealed a 1.5 x 1.5cm mobile mass on the left atrial side of the aso consistent with vegetation.When the aso was explanted, the left atrial side of the device was poorly endothelialized and a purulent fluid was present between the aso and atrial septum that was culture negative.Post-operatively, the patient received six weeks of vancomycin and recovered without further complications.The article briefly referenced a (b)(6) child with mitral valve prolapse who developed late aso endocarditis.

• 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: 5104003
• MDR Text Key: 26778524
• Report Number: 2135147-2015-00110
• 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: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9-ASD-032
• Device Catalogue Number: 9-ASD-032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 66 YR