AMPLATZER PICCOLO

Additional Manufacturer Narrative

SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER PICCOLO WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING PATENT DUCTUS ARTERIOSUS. COMPLICATIONS REPORTED INCLUDED DEVICE EMBOLIZATION, PATIENT DEVICE INTERACTION PROBLEM (RESIDUAL SHUNT), OBSTRUCTION, TRICUSPID REGURGITATION, UNEXPECTED MEDICAL INTERVENTION, DEATH; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. LITERATURE ATTACHMENT: PATENT DUCTUS ARTERIOSUS IN QATAR: A RETROSPECTIVE STUDY ON EPIDEMIOLOGY AND NEONATAL OUTCOMES FOLLOWING TRANSCATHETER CLOSURE. B2: DEATH DATE WAS ESTIMATED. 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, "PATENT DUCTUS ARTERIOSUS IN QATAR: A RETROSPECTIVE STUDY ON EPIDEMIOLOGY AND NEONATAL OUTCOMES FOLLOWING TRANSCATHETER CLOSURE", WAS REVIEWED. THIS LITERATURE ARTICLE IS A RETROSPECTIVE SINGLE-CENTER EXPERIENCE TO EVALUATE PATENT DUCTUS ARTERIOSUS (PDA) EPIDEMIOLOGY AND THE OUTCOMES OF TRANSCATHETER CLOSURE IN NEONATES WITH PDA IN QATAR AS WELL AS PROCEDURAL SUCCESS RATES, COMPLICATIONS AND FACTORS INFLUENCING OUTCOMES, INCLUDING PATIENT DEMOGRAPHICS AND PDA CHARACTERISTICS. THE DEVICE INCLUDED IN THE STUDY WAS AMPLATZER PICCOLO. THE ARTICLE CONCLUDED THAT TRANSCATHETER DEVICE CLOSURE DEMONSTRATES HIGH EFFIACY FOR PDA MANAGEMENT IN PRETERM INFANTS, WITH 100% ULTIMATE SUCCESS AFTER REPEAT INTERVENTIONS. LARGER PDA DIAMETER AND PRESENCE OF MURMUR SIGNIFICANTLY PREDICT THE NEED FOR CATHETER-BASED TREATMENT. [THE PRIMARY AUTHOR WAS SAFAA ELMOH, DIVISION OF MEDICAL EDUCATION, WEILL CORNELL MEDICINE¿QATAR, DOHA, QATAR.] [THE SECONDARY AND CORRESPONDING AUTHOR WAS HESHAM AL-SALOOS, DIVISION OF CARDIOLOGY, SIDRA MEDICINE, DOHA, QATAR, WITH CORRESPONDING E-MAIL: HALSALOOS@SIDRA.ORG.]. THIS STUDY INCLUDED INFANT PATIENTS DIAGNOSED WITH PDA WHO EITHER RECEIVED EITHER MEDICAL TREATMENT OR TRANSCATHETER DEVICE CLOSURE FROM 01 JANUARY 2018 TO 31 DECEMBER 2024. A TOTAL OF 80 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 66.25% (53) PATIENTS UNDERWENT TRANSCATHETER DEVICE CLOSURE, ALL OF WHICH WERE ABBOTT DEVICES. THE AVERAGE AGE WAS UNKNOWN. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED PATENT DUCTUS ARTERIOSUS.