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

Model Number 9-ASD-040

Device Problems Obstruction of Flow (2423); Migration (4003)

Patient Problems Edema (1820); Mitral Regurgitation (1964); Palpitations (2467)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient experienced paroxysmal palpitations, dyspnea, mitral valve regurgitation, an enlarged left atrium, and a low left ventricular ejection fraction 10 years after device implant.The device was explanted and was noted to have been compressing the annulus of the mitral valve.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

It was reported through a research article identifying an amplatzer septal occluder that may be related to a complication post procedure.Specific patient information is documented as a (b)(6) year old female.Details are listed in the article, titled "a long-term complication occurred after transcatheter closure of large atrial septal defect." on an unknown date, a (b)(6)-year-old patient was implanted with a 40mm amplatzer septal occluder.Ten years post procedure, the patient presented with paroxysmal palpitations and dyspnea for six months.Physician examination found a systolic murmur on the apical area of the heart and moderate edema of both lower limbs.A transthoracic echocardiogram showed a device at the atrial septal, severe mitral valve regurgitation, an enlarged left atrium, and a low left ventricular eject fraction.A surgical intervention was performed to remove the device.It was found that the device has endocardiolized in completely.The border of the device compressed the annulus of the mitral valve, leading to its geometric change.The device was removed and the defect was repaired with a pericardial patch.The patient was discharged seven days postoperative and showed improved cardiac function during the one-year follow-up.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL 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: 9649877
• MDR Text Key: 178353198
• Report Number: 2135147-2020-00037
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-040
• Device Catalogue Number: 9-ASD-040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2020
• 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): Other; Required Intervention
• Patient Age: 59 YR