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

Model Number 9-ASD-026

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 03/10/2015

Event Type  Injury  

Manufacturer Narrative

The results of this investigation confirmed the aso was covered in what appeared to be white tissue.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, as supported by review of the occluder's device history record.The cause for the reported event remains unknown.

Event Description

On (b)(6) 2015, a 26mm amplatzer septal occluder (aso) was implanted at (b)(6) hospital.On (b)(6) 2015, the patient was seen at the (b)(6) clinic and diagnosed with infective endocarditis secondary to chronic vegetations along with a persistent fever requiring the use of antibiotics.On (b)(6) 2016 the patient was referred to (b)(6) hospital to be monitored.Per report, the aso was explanted in (b)(6) 2016 and the patient was discharged on antibiotics.The patient had no pre-procedure history of endocarditis or any recent dental procedures.

• 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: 5497411
• MDR Text Key: 40240468
• Report Number: 2135147-2016-00028
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2016

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: No Information
• Device Expiration Date: 06/30/2019
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 4717593
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• 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