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

Model Number 9-ASD-014

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 04/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A 12 mm amplatzer septal occluder (aso) was implanted on (b)(6) 2011.On (b)(6) 2016, the patient presented to the emergency room with endocarditis.The patient was admitted to the hospital for diagnosis and treatment of endocarditis due to concerning physical findings.An echocardiogram demonstrated vegetation on the left atrial disc of the aso.A head mri demonstrated evidence of micro-embolic events with no neurologic symptoms.Iv antibiotic therapy was initiated.Cultures grew (b)(6).After 4-5 days of iv antibiotic therapy the first (b)(6) culture was obtained on (b)(6) 2016.Follow-up echo on (b)(6) 2016 demonstrated resolution of the left atrial vegetation.Follow-up mri demonstrated no new embolic events.The aso was electively removed by surgical intervention on (b)(6) 2016.In situ, the aso was completely endothelialized on the right atrial side at visual inspection; however, the left atrial side could not be examined prior to instrumentation during removal.The resulting atrial septal defect was closed and the patient was discharged home on (b)(6) 2016.The explanted aso culture was positive for candida parapsilosis.The patient continues iv antibiotics for (b)(6) and has started anti-fungal agents.Per report, the patient is doing well.

• 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: 5688391
• MDR Text Key: 46186084
• Report Number: 2135147-2016-00060
• 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
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2014
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: M09A09-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2009
• 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): Hospitalization; Required Intervention