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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Atrial Fibrillation (1729)

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.

Event Description

The following information was obtained from a 24 june 2017 literature article titled, "comparison on the efficacy and safety of different occlusion devices for the treatment of patients with patent foramen ovale." the aim of this study is to compare the efficacy and safety of cardi-o-fix pfo occluder and amplatzer pfo occluder for the treatment of patients with a pfo.Methods: a total of 246 consecutive patients with pfo were prospectively enrolled from may 30, 2013 to march 30, 2015.Pfo interventional closure was applied according to the anatomical structure of the disease and patients' wishes.Cardi-o-fix pfo occlude (cof group) was used in 180 case and the amplatzer pfo occlude (amp group) was used in the remaining 66 cases.Post-procedure safety including recurrent stroke, transient ischemic attack, death, and complete closure rate, and efficacy including procedure related complications of different devices were compared during the 12 months follow-up.Results: the rate of transient ischemic attack was similar between cof group (1.1%) and amp group (1.5%) at 12 months after the procedure.There was no recurrent stroke and deaths during the 12 months follow-up period.Complete closure rate was similar between cof group (90.6%) and amp group (86.4%) at 12 months after the procedure.There were three cases of paroxysmal atrial fibrillation in the cof group during the 12 months follow-up period.There was one patient that developed paroxysmal atrial fibrillation and was pharmacologically converted to sinus rhythm in the amp group.There was no complications such as occluder translocation, erosion, pericardial effusion and puncture site bleeding in the 2 groups during the 12 months follow-up.Conclusions: efficacy and safety are similar for pfo treatment with cardi-o-fix pfo occluder or amplatzer pfo occluder in this patient cohort.Doi: 10.3760/cma.J.Issn.0253-3758.2017.06.009.

• Brand Name: AMPLATZER PFO 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 ; 6517565400
• MDR Report Key: 6892091
• MDR Text Key: 87321884
• Report Number: 2135147-2017-00125
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• 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