FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA

Description of Event or Problem

WHEN THE PATIENT WAS 233 DAYS OF AGE, THE FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED. THE MAGNETS WERE PLACED IN THE DISTAL MOST PORTION OF THE ESOPHAGEAL ENDS. THE RESULTING GAP MEASUREMENT WAS 4 CM. ANASTOMOSIS WAS NOT ACHIEVED AFTER 13 DAYS. SURGICAL INTERVENTION (OPEN REPAIR) WAS PROVIDED TO CLOSE THE PRE-EXISTING ESOPHAGEAL GAP AT 29 DAYS FROM REMOVAL OF THE FLOURISH DEVICE. THIS EVENT OF UNABLE TO ACHIEVE ANASTOMOSIS AND SURGICAL REPAIR OF THE PRE-EXISTING ATRETIC GAP IS CAPTURED IN EMDR 1037905-2019-00087. ON 07 FEBRUARY 2023 THROUGH INFORMATION RECEIVED VIA THE FLOURISH POST APPROVAL STUDY, IT WAS DETERMINED THAT ON THE SAME DAY OF THE PATIENT'S OPEN REPAIR SURGERY (29 DAYS AFTER FLOURISH REMOVAL), THE PATIENT WAS DIAGNOSED WITH TRACHEOMALACIA. NO TREATMENT WAS PROVIDED. THE SITE CONSIDERED THIS EVENT POSSIBLY RELATED TO BOTH THE FLOURISH DEVICE AND THE PROCEDURE, STATING ¿SOME TRACHEOMALACIA IDENTIFIED AFTER PLACEMENT OF FLOURISH DEVICE [SUBJECT OF THIS REPORT]."

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED THE PATIENT WAS DIAGNOSED WITH TRACHEOMALACIA. THE COMPLICATION REPORTED IS A KNOWN CLINICAL COMPLICATION. THE USER INDICATED THE CAUSE OF THE TRACHEOMALACIA WAS POSSIBLY RELATED TO BOTH THE FLOURISH DEVICE AND THE PROCEDURE. THERE IS NO EVIDENCE TO SUGGEST THE REPORT IS DUE TO A DEVICE FAILURE. THE IFU STATES: "POTENTIAL COMPLICATIONS FOLLOWING SUCCESSFUL ANASTOMOSIS INCLUDE: GASTROESOPHAGEAL REFLUX, TRACHEOMALACIA, ESOPHAGEAL DYSMOTILITY, RECURRENT ASTHMA, AND PULMONARY INFECTIONS." PRIOR TO DISTRIBUTION, ALL FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.