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

Model Number 9-ASD-030

Device Problem Unintended Movement (3026)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

The results of this investigation are inconclusive because the amplatzer septal occluder was not returned for evaluation.A review of the device history record could not be completed because the batch/lot # was not provided.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the reported event remains unknown.

Event Description

The following was obtained from a literature article titled, "an usual complication after percutaneous closure of a mitral para-annular/valvular leak" from the european heart journal 2016 37 supplement 1 (1413).A (b)(6) gentleman presented with heart failure symptoms (nyha iii).An echocardiogram showed a left ventricular ejection fraction of 34% with inferior akinesia as well as a severe mitral regurgitation with posterior leaflet restriction.A cardiac mri demonstrated absence of viability in inferior territory (myocardial infarction scar) and a coronary angiogram showed a 70-90% stenosis of proximal left anterior descending artery.He underwent a mitral valve reconstruction with annuloplasty and cabg (left internal mammary artery to left anterior descending artery) but the procedure was complicated by cardiac tamponade treated with a pericardiocentesis.Furthermore, a transesophageal echocardiography demonstrated an important paravalvular leak and the patient was referred to our center for percutaneous closure.After a transseptal puncture under transesophageal guidance and an antegrade leak crossing, a severe para-annular postero-septal leak was closed with a 16 mm amplatzer muscular vsd occluder.However, the procedure was complicated by an important laceration of interatrial septum by the guiding with large communication and an important shunt.A closure with a 30 mm amplatzer septal occluder (aso) was performed with good result.The patient was transferred to intensive care unit for observation.A few hours later, the patient developed desaturation (80%) and was brought to the cath lab.The angiogram demonstrated an embolization of the aso into the right atrium.In order to retrieve it, a jr4 8f guiding catheter was used with a retrieval forceps vr (cook medical) to trap the aso which was then withdrawn and stabilized in the inferior vena cava.Then, with addition of an amplatzer gooseneck microsnare (covidien), the insertion screw of the aso was snared and a percutaneous femoral extraction was performed.Finally, a 40 mm aso was used to close the laceration with success.

• 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: 6861092
• MDR Text Key: 85923248
• Report Number: 2135147-2017-00108
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P000039
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR