FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA

Description of Event or Problem

A PATIENT WITH PRE-EXISTING PEDIATRIC ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. SEVENTEEN (17) DAYS POST-PLACEMENT, SUCCESSFUL ANASTOMOSIS WAS ACHIEVED. THE FLOURISH DEVICE WAS REMOVED ON THE SAME DAY. AT 17 DAYS FOLLOWING FLOURISH DEVICE PLACEMENT, THE PATIENT WAS DIAGNOSED WITH A LEFT PNEUMOTHORAX AND RESPIRATORY INSUFFICIENCY. TREATMENT INCLUDED PLACEMENT OF A ¿12 FRENCH CHEST TUBE PLACED IN L PLEURAL CAVITY¿ AND MONITORING. THE PNEUMOTHORAX RESOLVED 10 DAYS AFTER ONSET AND THE RESPIRATORY INSUFFICIENCY RESOLVED 13 DAYS AFTER ONSET. THE STUDY SITE ASSESSED THE PNEUMOTHORAX AS ¿POSSIBLY¿ RELATED TO THE FLOURISH DEVICE AND NOTED THE FOLLOWING, ¿UNKNOWN IF THERE WAS SMALL LEAK CAUSED BY DEVICE LEADING TO PTX¿ AND ¿POSSIBLY¿ RELATED TO THE STUDY PROCEDURE AND NOTED THE FOLLOWING, ¿USE OF DEVICE MAY HAVE CAUSED SMALL LEAK.¿ THE RESPIRATORY INSUFFICIENCY WAS CONSIDERED ¿POSSIBLY¿ RELATED TO BOTH DEVICE AND PROCEDURE AS WELL; THE SITE NOTED THAT THE RESPIRATORY INSUFFICIENCY WAS RELATED TO THE PNEUMOTHORAX. DEFINITION PROVIDED OF "POSSIBLY RELATED": THE RELATIONSHIP IS WEAK BUT CANNOT BE COMPLETELY RULED OUT.

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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED THE PATIENT WAS DIAGNOSED WITH PNEUMOTHORAX AND RESPIRATORY INSUFFICIENCY. THE COMPLICATIONS REPORTED ARE KNOWN CLINICAL COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE REPORT IS DUE TO A DEVICE FAILURE. THE IFU STATES, "POTENTIAL COMPLICATIONS DURING THE DEVICE INDWELLING PERIOD ALSO INCLUDE PERFORATION/LEAK OF ONE OR BOTH ESOPHAGEAL POUCHES OR ANASTOMOTIC SITE, WHICH COULD RESULT IN ADDITIONAL PROCEDURES AND/OR DEATH." PRIOR TO DISTRIBUTION, ALL FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. 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.

Additional Manufacturer Narrative

SECTION B5 WAS UPDATED WITH NEW INFORMATION FROM THE PHYSICIAN.

Description of Event or Problem

A PATIENT WITH PRE-EXISTING PEDIATRIC ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. SEVENTEEN (17) DAYS POST-PLACEMENT, SUCCESSFUL ANASTOMOSIS WAS ACHIEVED. THE FLOURISH DEVICE WAS REMOVED ON THE SAME DAY. AT 17 DAYS FOLLOWING FLOURISH DEVICE PLACEMENT, THE PATIENT WAS DIAGNOSED WITH A LEFT PNEUMOTHORAX AND RESPIRATORY INSUFFICIENCY. TREATMENT INCLUDED PLACEMENT OF A ¿12 FRENCH CHEST TUBE PLACED IN L PLEURAL CAVITY¿ AND MONITORING. THE PNEUMOTHORAX RESOLVED 10 DAYS AFTER ONSET AND THE RESPIRATORY INSUFFICIENCY RESOLVED 13 DAYS AFTER ONSET. THE STUDY SITE ASSESSED THE PNEUMOTHORAX AS ¿POSSIBLY¿ RELATED TO THE FLOURISH DEVICE AND NOTED THE FOLLOWING, ¿UNKNOWN IF THERE WAS SMALL LEAK CAUSED BY DEVICE LEADING TO PTX¿ AND ¿POSSIBLY¿ RELATED TO THE STUDY PROCEDURE AND NOTED THE FOLLOWING, ¿USE OF DEVICE MAY HAVE CAUSED SMALL LEAK.¿ THE RESPIRATORY INSUFFICIENCY WAS CONSIDERED ¿POSSIBLY¿ RELATED TO BOTH DEVICE AND PROCEDURE AS WELL; THE SITE NOTED THAT THE RESPIRATORY INSUFFICIENCY WAS RELATED TO THE PNEUMOTHORAX. DEFINITION PROVIDED OF "POSSIBLY RELATED": THE RELATIONSHIP IS WEAK BUT CANNOT BE COMPLETELY RULED OUT. NEW INFORMATION RECEIVED FROM THE PHYSICIAN AT THE STUDY SITE: THE FOLLOWING WAS RECEIVED ON 01/12/2023: "PNEUMOMEDIASTINUM AND SUBCUTANEOUS EMPHYSEMA WAS MENTIONED ALONG WITH THE PNEUMOTHORAX. LOCATION FOR PNEUMOTHORAX WAS LEFT LUNG." PNEUMOMEDIASTINUM AND SUBCUTANEOUS EMPHYSEMA ARE SEQUELA OF THE PNEUMOTHORAX AND WERE TREATED WITH THE CHEST TUBE. FURTHER INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 02/07/2023: ¿[IT IS] UNKNOWN IF THERE WAS SMALL LEAK CAUSED BY DEVICE LEADING TO PNEUMOTHORAX. WE SUSPECT A SMALL ANTERIORLY LAYERING PNEUMOTHORAX ALONG THE UPPER TO MID LUNG. DEVICE REMOVAL WAS NOT DUE TO PNEUMOTHORAX. PNEUMOTHORAX WAS DISCOVERED AFTER MAGNET REMOVAL. AN ESOPHAGRAM WAS DONE 5 DAYS AFTER REMOVAL TO CHECK FOR PATENCY LEAK. THE ROOT CAUSE OF PNEUMOTHORAX IS UNKNOWN; IT IS UNKNOWN IF IT WAS CAUSED BY THE DEVICE.¿

Description of Event or Problem

A PATIENT WITH PRE-EXISTING PEDIATRIC ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. SEVENTEEN (17) DAYS POST-PLACEMENT, SUCCESSFUL ANASTOMOSIS WAS ACHIEVED. THE FLOURISH DEVICE WAS REMOVED ON THE SAME DAY. AT 17 DAYS FOLLOWING FLOURISH DEVICE PLACEMENT, THE PATIENT WAS DIAGNOSED WITH A LEFT PNEUMOTHORAX AND RESPIRATORY INSUFFICIENCY. TREATMENT INCLUDED PLACEMENT OF A ¿12 FRENCH CHEST TUBE PLACED IN L PLEURAL CAVITY¿ AND MONITORING. THE PNEUMOTHORAX RESOLVED 10 DAYS AFTER ONSET AND THE RESPIRATORY INSUFFICIENCY RESOLVED 13 DAYS AFTER ONSET. THE STUDY SITE ASSESSED THE PNEUMOTHORAX AS ¿POSSIBLY¿ RELATED TO THE FLOURISH DEVICE AND NOTED THE FOLLOWING, ¿UNKNOWN IF THERE WAS SMALL LEAK CAUSED BY DEVICE LEADING TO PTX¿ AND ¿POSSIBLY¿ RELATED TO THE STUDY PROCEDURE AND NOTED THE FOLLOWING, ¿USE OF DEVICE MAY HAVE CAUSED SMALL LEAK.¿ THE RESPIRATORY INSUFFICIENCY WAS CONSIDERED ¿POSSIBLY¿ RELATED TO BOTH DEVICE AND PROCEDURE AS WELL; THE SITE NOTED THAT THE RESPIRATORY INSUFFICIENCY WAS RELATED TO THE PNEUMOTHORAX. DEFINITION PROVIDED OF "POSSIBLY RELATED": THE RELATIONSHIP IS WEAK BUT CANNOT BE COMPLETELY RULED OUT. NEW INFORMATION RECEIVED FROM THE PHYSICIAN AT THE STUDY SITE: THE FOLLOWING WAS RECEIVED ON 01/12/2023: "PNEUMOMEDIASTINUM AND SUBCUTANEOUS EMPHYSEMA WAS MENTIONED ALONG WITH THE PNEUMOTHORAX. LOCATION FOR PNEUMOTHORAX WAS LEFT LUNG." PNEUMOMEDIASTINUM AND SUBCUTANEOUS EMPHYSEMA ARE SEQUELA OF THE PNEUMOTHORAX AND WERE TREATED WITH THE CHEST TUBE.

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 PNEUMOTHORAX AND RESPIRATORY INSUFFICIENCY. THE COMPLICATIONS REPORTED ARE KNOWN CLINICAL COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE REPORT IS DUE TO A DEVICE FAILURE. THE IFU STATES, "POTENTIAL COMPLICATIONS DURING THE DEVICE INDWELLING PERIOD ALSO INCLUDE PERFORATION/LEAK OF ONE OR BOTH ESOPHAGEAL POUCHES OR ANASTOMOTIC SITE, WHICH COULD RESULT IN ADDITIONAL PROCEDURES AND/OR DEATH." 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.