Additional Manufacturer Narrative · 1
ORIGINAL SURGERY WAS PERFORMED BY DR IN 1999, USING HUTCHISON HSH 400 SALINE-FILL IMPLANTS, WHICH WERE FILLED TO AN UNK VOLUME. THE PT UNDERWENT BILATERAL REPLACEMENT SURGERY IN 2007. THE IMPLANTS WERE REPLACED WITH MCGHAN 425 HIGH PROFILE SALINE FILL IMPLANTS THAT WERE FILLED TO A VOLUME OF 445CC. VISUAL INSPECTION IDENTIFIED A VALVE SHELL TEAR THAT MEASURES APPROX 2MM IN LENGTH, WHICH IS LOCATED ON THE 6 O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). ALSO IDENTIFIED ON THE PRODUCT WAS A BREACH THAT MEASURES APPROX 24MM IN TOTAL LENGTH THAT STARTED ON THE ANTERIOR SURFACE, WHICH EXTENDS ONTO THE POSTERIOR SURFACE. PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE SIZE AND POSITION OF THE BREACH. MICROSCOPIC EXAMINATION (X10) OF THE VALVE-SHELL TEAR IDENTIFIED REGGED EDGES, WHICH ARE INDICATIVE OF AN EXCESSIVE FORCE HAVING BEING USED. MICROSCOPIC EXAMINATION (X10) OF THE BREACH IDENTIFIED A CLEAR "V" SHAPED INITIATION POINT AND WELL DEFINED EDGES WHICH ARE INDICATIVE OF MECHANICAL TRAUMA. THE PRODUCT MET ALL MFG AND QUALITY SPECIFICATIONS POST MFR. THE VALVE-SHELL TEAR IS NOT A MFG FAULT.