AS REQUESTED THE SURGEON WAS PROVIDED WITH A DOCTOR TO DOCTOR CONSULT. BASED ON INFORMATION OBTAINED FOLLOWING THE CONSULT IT APPEARS THAT THE PATIENT WAS EXPERIENCING AN EXAGGERATED FOREIGN BODY RESPONSE, IT ALSO APPEARS THAT THE GRAFT WAS NOT PLACED FLAT WHICH COULD CONTRIBUTE TO THE REPORTED INCORPORATION OF THE GRAFT. THE PRECAUTION SECTION OF THE IFU STATES, PLACE DEVICE IN MAXIMUM POSSIBLE CONTACT WITH HEALTH, WELL VASCULARIZED TISSUE TO PROMOTE CELL INGROWTH AND TISSUE REMODELING. INFLAMMATION AND ALLERGIC REACTION OR HYPERSENSITIVITY TO DEVICE MATERIALS ARE LISTED IN THE ADVERSE REACTION SECTION OF THE IFU AS POSSIBLE COMPLICATIONS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT CODE AND LOT NUMBER OF THE XENMATRIX AB GRAFT, HOWEVER THE USER WAS NOT WILLING TO PROVIDE THIS INFORMATION. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. ADDITIONALLY, THE EXPLANTED GRAFT WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, NO DEFINITIVE CONCLUSION CAN BE MADE AS TO WHY THE GRAFT DID NOT INCORPORATE AND BECAME ENCAPSULATED. SHOULD ADDITIONAL DETAILS BE PROVIDED, A SUPPLEMENTAL MDR 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. NOT RETURNED.
D
Patient 1
IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE IN WHICH THE SURGEON USED THE XENMATRIX AB IN THE ABDOMEN AS AN OVERLAY GRAFT ON THE RECTUS SHEATH TO REINFORCE A TRAM/DIEP. THE SURGEON REPORTS THE GRAFT INCREASED IN THICKNESS SINCE IMPLANT AND HAD NOT INCORPORATED. THE SURGEON ALSO REPORTS INFLAMMATION AND THE PATIENT IS COMPLAINING OF SEVERE PAIN. A PORTION OF THE GRAFT WAS SENT FOR CULTURE WITH RESULTS SHOWING NO INFECTION. DURING A REOPERATION PROCEDURE IT WAS NOTED THAT THE GRAFT HAD BECOME ENCAPSULATED AND THE GRAFT WAS REMOVED. THE SURGEON CONTACTED DAVOL AND REQUESTED A SURGEON CONSULT REGARDING THIS CASE.
N
Patient 1
THIS AN ADDENDUM TO THE INITIAL MDR TO DOCUMENT THE RECEIPT OF MAUDE EVENT REPORT (MW5069553). MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO THE REPORTER, WHO RESPONDED THAT SHE HAS BEEN UNAVAILABLE AND WOULD RESPOND TO THE REQUEST WHEN POSSIBLE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL MDR 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.
D
Patient 1
AS REPORTED BY THE SURGEON: IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE IN WHICH THE SURGEON USED THE XENMATRIX AB IN THE ABDOMEN AS AN OVERLAY GRAFT ON THE RECTUS SHEATH TO REINFORCE A TRAM/DIEP. THE SURGEON REPORTS THE GRAFT INCREASED IN THICKNESS SINCE IMPLANT AND HAD NOT INCORPORATED. THE SURGEON ALSO REPORTS INFLAMMATION AND THE PATIENT IS COMPLAINING OF SEVERE PAIN. A PORTION OF THE GRAFT WAS SENT FOR CULTURE WITH RESULTS SHOWING NO INFECTION. DURING A REOPERATION PROCEDURE IT WAS NOTED THAT THE GRAFT HAD BECOME ENCAPSULATED AND THE GRAFT WAS REMOVED. THE SURGEON CONTACTED DAVOL AND REQUESTED A SURGEON CONSULT REGARDING THIS CASE. ADDENDUM PER MAUDE EVENT REPORT (MW5069553) AS REPORTED BY THE PATIENT: "XEN AB WAS USED IN BILATERAL RECONSTRUCTION WITH TRAM FLAP AND UMBILICAL HERNIA REPAIR. MESH HAS HARDENED INTO A "BONE LIKE" MATTER AND HAS CAUSED EXCRUCIATING PAIN AND DISABILITY. SUBSEQUENT SURGERIES PERFORMED AND EXTENSIVE LIFESTYLE LIMITATIONS HAS OCCURRED