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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Manufacturer Narrative

An event of atrial septal defect was reported.The results of the investigation are inconclusive since the device was not returned for analysis.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 literature articled titled, minimally invasive endoscopic surgery versus catheter-based device occlusion for atrial septal defects in adults: reconsideration of the standard of care, from the journal of interact cardiovasc thorac surg.(2017 apr 1;24(4):603-608).Objectives: percutaneous ostium secundum atrial septal defect (asd ii) closure has become the standard of care for treatment of congenital asd ii in adults.Nevertheless, patients are frequently ineligible for this technique due to challenging morphology.In such cases, closure via minimally invasive cardiac surgery (mics) is an appropriate treatment option.The aim of this study is to compare outcomes of mics and use of a percutaneous amplatzer septal occluder (aso) device for treatment of asd ii in adults.Methods: from july 2002 to june 2014, 95 patients underwent mics for congenital asd ii closure.During the same period, 169 patients underwent aso procedure.Outcomes in terms of remaining asd ii, new onset atrial fibrillation (af), post-interventional stroke, myocardial infarction and the post procedural implementation of anticoagulation were compared.Results: apart from age (38.3 ± 12.7 vs 49.6 ± 15.7 years, p < 0.0001) the groups did not differ in baseline characteristics.A significantly higher rate of residual asd ii was found in the aso group at 3 months (0% vs 30.8%, p < 0.0001), 6 months (0% vs 15.9%, p < 0.0001) and 12 months follow-up (0% vs 7.1%, p = 0.005).A significantly higher rate of new-onset af was seen in the aso group (0% vs 9.5%, p = 0.0008).Conclusions: mics for asd ii is a safe and reproducible procedure with 0% mortality in our cohort.More complete closure of asd, decreased rates of new onset af and decreased need for oral anticoagulation are the advantages of the mics procedure.Compared with the current standard of care, the mics approach is feasible regardless of asd morphology.Patient identifier, age, weight and gender is protected under local privacy laws, and therefore is not recorded.

• 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: 7145293
• MDR Text Key: 95726661
• Report Number: 2135147-2017-00188
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2017
• 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: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention