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

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

Patient Problems Atrial Fibrillation (1729); Mitral Regurgitation (1964); Pleural Effusion (2010)

Event Type  Injury  

Manufacturer Narrative

Events of worsening heart failure with pleural effusions, mitral regurgitation, pulmonary hypertension, and atrial fibrillation were 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 comes from the abstract of the "structure club japan live demonstration 2017" held on november 4-5, 2017, p.57-001.On an unknown date in 2010, an atrial septal defect (asd) was diagnosed and an amplatzer septal occluder (aso) (model/lot: unknown) was implanted at another hospital.Since (b)(6) 2014, lower extremity edema was present, and the patient was hospitalized for intensive examination and treatment.Furthermore, bilateral pleural effusions, mitral regurgitation (mr) and atrial fibrillation (af) were confirmed.The patient was diagnosed with heart failure (hf) and admitted to the hospital.After admission, heart failure was controlled by internal therapy.On an unknown date in (b)(6) 2014, the patient was referred to cardiovascular center for follow-up treatment.At the initial visit, moderate to severe mr was reported to be observed due to prolapse at the area between the position of a2 and p2 in the patient's native mitral valve.The patient had been monitored with administration of beta blocker without worsening of hf.Since (b)(6) 2016, recurrent edema in the lower extremities was noted.The patient was re-admitted to a local clinic for the treatment.However, the symptoms of respiratory discomfort during the night were gradually experienced.On an unknown date in (b)(6) 2017, the patient presented again with pulmonary hypertension and hepatic congestion and the patient was hospitalized and treated for hf.After the treatment of hf, mitral valve replacement (mvr) due to the prolapse in the mitral position was performed.The aso remain implanted.Worsening of mr was reported to be exhibited during chronic phase after asd closure.The author considered that mitral valve prolapse (mvp) and worsening of mr after asd closure were most likely to be caused by a patient's native annulus and ventricular remodeling due to long-term asd.Thus the procedure of aso deployment could have been related to this event.Patient specific information of patient identifier, birthdate and weight are not available for this complaint.No further information including the patient's post-operative condition other than which is written in this literature is available.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUDER
• 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
• MDR Report Key: 7295418
• MDR Text Key: 100889082
• Report Number: 2135147-2018-00021
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 76 YR