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

Device Problem Unintended Movement (3026)

Patient Problem Embolism (1829)

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 information comes from the abstract titled "surgical treatment of complications after transcatheter intervention for atrial septal defect (asd) closure." three days post implant of an amplatzer septal occluder (aso) during the predischarge echocardiogram, the aso was found embolized to the bifurcation of the right pulmonary artery.An emergency surgery was performed where the aso was removed and the asd was closed with an autologous pericardial patch.According to the author, adaptability of aso should be deliberated for use in cases that a portion of patient's rim is absent.In this case the patient's asd had a deficient inferior rim.(b)(6).

• 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 ; 6517565400
• MDR Report Key: 6875230
• MDR Text Key: 86588503
• Report Number: 2135147-2017-00110
• 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
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA 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): Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 41