AEROFORM® TISSUE EXPANDER SYSTEM, MEDIUM, V2.5

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO AIRXPANDERS ON DEC-15-2017 AND THE EVALUATION WAS COMPLETED ON FEB 15 -2018. THE DATE OF EXPLANT IS UNKNOWN. THE RETURNED IMPLANT WAS DECONTAMINATED AND EVALUATED. VISUAL INSPECTION OF THE RETURNED IMPLANT WAS PERFORMED. THE INNER BAG WAS EXAMINED VISUALLY UNAIDED AND WITH UP TO 40X MAGNIFICATION. THE REPORTED RIGHT EXPANDER'S ANTERIOR PANEL SHOWS MODERATE WEAR/CREASES WITH MOST WEAR WITHIN THE OUTER ANTERIOR PANEL. THE SEAL PERIMETER WITH SEVERE DELAMINATION OF THE BARRIER FILM LAYERS. THE RIGHT EXPANDER'S POSTERIOR PANEL HAD SEVERE AMOUNT OF DISTRESS POINTS AND SEVERE DELAMINATION IN SEAL PERIMETER. BUBBLE IMMERSION TEST CONFIRMED LEAKAGE. THE DISASSEMBLY OF THE RIGHT IMPLANT REVEALED A DIRECT PATH FOR BIOLOGICAL FLUID COMMUNICATION THROUGH ANTERIOR INNER LUMEN PANEL. THE DOSAGE DATA REVEALED THAT THERE WAS NO PATIENT DOSING MORE THAN 7 DAYS FOLLOWING IMPLANTATION. THE MOST PROBABLE ROOT CAUSE OF THE RIGHT EXPANDER MALFUNCTION WAS DETERMINED TO BE MODERATE TO SEVERE WEAR IN THE OVERALL IMPLANT, LEADING TO A BREACH THROUGH THE INNER BAG AND SUBSEQUENT FOULING THAT CAUSED THE VALVE TO STICK OPEN DUE TO BIOLOGICAL FLUID INGRESS. THIS TYPE OF MALFUNCTION CAN OCCUR WHEN THE DEVICE IS IMPLANTED BEYOND THE INDICATED 6 MONTH PERIOD.THIS WAS SEEN IN THIS VERSION (V2.5) OF THE DEVICE.THE CURRENT VERSION HAS BEEN IMPROVED THROUGH A MATERIAL CHANGE TO THE INNER LINER WHICH HAS SHOWN SIGNIFICANTLY IMPROVED RESISTANCE TO THIS TYPE OF WEAR DAMAGE. THE TISSUE EXPANDERS REMAINED IMPLANTED FOR APPROXIMATELY 18 MONTHS (IMPLANTED ON (B)(6) 2016). THE INSTRUCTION FOR USE CLEARLY STATES THAT "THE AEROFORM TISSUE EXPANDER IS INTENDED FOR TEMPORARY SUBCUTANEOUS OR SUBMUSCULAR IMPLANTATION AND IS NOT INTENDED FOR USE BEYOND 6 MONTHS". THIS FOLLOW UP REPORT ALSO CORRECTS THE CATALOG NUMBER PREVIOUSLY REPORTED ON JUNE-22-2017. THE CATALOG NUMBER FOR THIS DEVICE IS LP120-650. THE REPORT ALSO CORRECTS THE DEVICE EVALUATED BY MANUFACTURER PREVIOUSLY REPORTED ON JUNE-05-2017.

Additional Manufacturer Narrative

THIS FOLLOW UP REPORT CORRECTS THE MODEL NUMBER PREVIOUSLY REPORTED. THE MODEL NUMBER FOR THIS DEVICE IS LP120-650.

Additional Manufacturer Narrative

THE RIGHT TISSUE EXPANDER S/N (B)(4) IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED UNTIL THE PATIENT'S PLANNED RADIATION TREATMENT HAS CONCLUDED, AND AFTER THE SURGEON FEELS IT IS MEDICALLY FEASIBLE TO REMOVE. THE TISSUE EXPANDERS HAVE BEEN IMPLANTED FOR APPROXIMATELY 11 MONTHS (IMPLANTED ON (B)(6) 2016). THE AEROFORM® TISSUE EXPANDER IS NOT INTENDED FOR IMPLANT USE BEYOND 6 MONTHS AS PER ITS INDICATIONS FOR USE. THE OVER-EXPANSION OF THE DEVICE MAY BE DUE TO PROLONGED USE OF THE DEVICE BEYOND ITS RECOMMENDED LABELED USE. (B)(4).

Description of Event or Problem

THE SURGEON REPORTED THE PATIENT HAD NOT EXPANDED SINCE IMPLANTATION ((B)(6) 2016). THE PATIENT HAD NOT STARTED HOME EXPANSION DUE TO MULTIPLE MEDICAL COMPLICATIONS AND VISIT NON-COMPLIANCE. ON (B)(6) 2017, THE SURGEON PLANNED TO EXPAND THE PATIENT TO 100CC ON EACH SIDE PRIOR TO THE PATIENT BEGINNING RADIATION TREATMENT. THE PATIENT'S LEFT TISSUE EXPANDER WAS INITIALLY EXPANDED BY 50CC OF CO2 WITHOUT ISSUE. THE SURGEON THEN PROCEEDED TO EXPAND THE RIGHT SIDE, AND AFTER APPROXIMATELY 20CC TO 30CC EXPANSION, IT WAS OBSERVED THE RIGHT EXPANDER CONTINUED TO EXPAND QUICKLY AND BECAME FIRM RESULTING IN DISCOMFORT TO THE PATIENT. THE SURGEON INSERTED AN 18-GAUGE NEEDLE INTO THE RIGHT EXPANDER TO DEFLATE IT TO RELIEVE PATIENT DISCOMFORT. THE PATIENT WILL PROCEED WITH RADIATION TREATMENT, AND THE EXPANDERS WILL BE EXPLANTED WHEN IT IS MEDICALLY FEASIBLE TO DO SO.