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

Model Number 9-ASD-MF-035

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Dyspnea (1816); Regurgitation (2259)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Approximately one month following implant of a 35mm amplatzer cribriform occluder (aco), the patient returned complaining of recurring dyspnea with an increase in symptoms.On (b)(6) 2016, the patient was brought to the cath lab after ice and tee revealed a left-to-right shunt.The physician opted to remove the 35mm aco as he felt the 35mm aco was too big and may have been keeping the defect open.The defect was then balloon-sized and an 18mm amplatzer septal occluder (aso) was attempted but not released.Repeat ice imaging revealed an ongoing shunt and the 18mm aso was percutaneously retrieved.The patient was referred for a cardiac mri to further investigate the defect anatomy.The patient was stable throughout the procedure.No additional devices were attempted and the patient will be reconsidered for surgery in the future.

• Brand Name: AMPLATZER CRIBRIFORM 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: 5950360
• MDR Text Key: 54700600
• Report Number: 2135147-2016-00087
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039/S013
• 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: 09/01/2016

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: Physician
• Device Model Number: 9-ASD-MF-035
• Device Catalogue Number: 9-ASD-MF-035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/14/2016
• 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