THERE WAS NO CONNECTION THAT CAN BE MADE BETWEEN THE REPORTED POSTOPERATIVE COMPLICATION (SEROMA) AND ANY PROBLEM WITH THE XENMATRIX AB GRAFT USED TO TREAT THE PATIENT. THE GRAFT REMAINS IMPLANTED. NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. SEROMA FORMATION IS A KNOWN INHERENT RISK OF SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POTENTIAL COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. REMAINS IMPLANTED.
D
Patient 1
IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY HAS BEEN DIAGNOSED WITH A SEROMA. ON (B)(6) 2017 THE SUBJECT PATIENT UNDERWENT REPAIR OF A SUBXIPHOID, EPIGASTRIC HERNIA USING A XENMATRIX AB GRAFT. CONCOMITANT PROCEDURES WERE ALSO PERFORMED AT THIS TIME AND INCLUDED, REMOVAL OF DEEP FOREIGN BODIES, MUSCLE X2, AN ADJACENT TISSUE TRANSFER AND LYSIS OF ADHESIONS. THE HERNIA IS NOTED TO BE A PRIMARY VENTRAL HERNIA AND ASSESSED TO BE A CLASS 1 (CLEAN) WOUND SITE PRE OPERATIVELY. THE CASE WAS PERFORMED IN RETRO RECTUS FASHION WITH COMPONENT SEPARATION TECHNIQUE (POSTERIOR). A TAR (TRANSVERSUS ABDOMINIS MUSCLE RELEASE) TECHNIQUE WAS UTILIZED. XENMATRIX AB GRAFT WAS PLACED WITH A 5CM GRAFT OVERLAP AROUND THE HERNIA DEFECT. LONG-TERM ABSORBABLE MONOFILAMENT SUTURE WAS USED FOR PERIMETER FIXATION OF THE GRAFT. THE MIDLINE FASCIA WAS COMPLETELY CLOSED. THE SKIN WAS NOT FULLY CLOSED AND A VACUUM ASSISTED CLOSURE WAS PERFORMED. DRAINS WERE INSERTED IN THE RIGHT UPPER QUADRANT, LEFT UPPER QUADRANT AND IN THE SUBCUTANEOUS SPACE. THE DRAINS AND VACUUM WERE REMOVED ON (B)(6) 2017 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2017 THE PATIENT WAS DIAGNOSED WITH A SEROMA. INTERVENTION HAS NOT BEEN SPECIFIED. CRF INDICATES THE AE HAS BEEN RESOLVED WITH AN END DATE OF (B)(6) 2017. THE AE OF SEROMA WAS ASSESSED BY THE HEALTH PROFESSIONAL AS BEING POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE SEROMA WAS CONSIDERED A GRADE 3 WITH A SEVERITY RATING OF SERIOUS.