AMPLATZER DUCT OCCLUDER II

Additional Manufacturer Narrative

A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION LITERATURE ATTACHMENT: CATASTROPHIC PEDIATRIC STROKE FOLLOWING ATTEMPTED TRANSCATHETER VENTRICULAR SEPTAL DEFECT CLOSURE. B3: EVENT DATE WAS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

Description of Event or Problem

THE ARTICLE, "CATASTROPHIC PEDIATRIC STROKE FOLLOWING ATTEMPTED TRANSCATHETER VENTRICULAR SEPTAL DEFECT CLOSURE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF AN 18-MONTH-OLD FEMALE PATIENT WITH A HISTORY OF ATRIAL SEPTAL DEFECT, PROGRESSIVE AORTIC CUSP PROLAPSE, MILD AORTIC REGURGITATION, LEFT VENTRICULAR VOLUME OVERLOAD, AND PERSISTENT FAILURE TO THRIVE. ON AN UNKNOWN DATE A 4MM X 4MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE. DURING DEPLOYMENT THE PATIENT PRESENTED WITH NEW ONSET TRICUSPID AND WORSENING AORTIC REGURGITATION. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS CANCELLED. POSTPROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED NO NEW TRICUSPID REGURGITATION AND THE SAME DEGREE OF MILD AORTIC VALVE PROLAPSE AND REGURGITATION AFTER THE DEVICE WAS REMOVED. TWO HOURS POST-PROCEDURE THE PATIENT DEVELOPED PROGRESSIVE DROWSINESS, BRADYCARDIA, RELATIVE HYPERTENSION, AND RIGHT PUPIL DILATION. THE PATIENT WAS REINTUBATED AND TREATED WITH HYPEROSMOLAR THERAPY. A COMPUTED TOMOGRAPHY (CT) SCAN 3 HOURS POST-PROCEDURE DEMONSTRATED A LARGE RIGHT HEMISPHERIC INFARCTION, MIXED-DENSITY SUBDURAL COLLECTION, AND UNCAL HERNIATION INDICATIVE OF A STROKE. A DECOMPRESSIVE CRANIECTOMY AND EXCAVATION OF SUBDURAL HEMATOMA WAS PERFORMED. THE PATIENT WAS DISCHARGED AFTER TWO MONTHS. FOLLOW-UP DEMONSTRATED NEAR-COMPLETE NEUROLOGICAL RECOVERY. [THE PRIMARY AND CORRESPONDING AUTHOR WAS SUPAPORN ROYMANEE, DEPARTMENT OF PEDIATRICS, FACULTY OF MEDICINE, PRINCE OF SONGKLA UNIVERSITY, HAT YAI, SONGKHLA 90110, THAILAND, WITH CORRESPONDING E-MAIL: JIEWSR@YAHOO.COM.]