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According to the report ,the surgeon "will be seeing a patient today with an exposed titanium connector.The hero was placed by" another surgeon and "is the second time the hero connector has eroded through the patient's skin.She is going to try to revise it." on (b)(6) 2016 additional information from the surgeon was received in an email.The surgeon was asked if she knew the date of implant and the date when the issue was first noticed, her reply was, "(b)(6) 2015, from what i can gather from the record, (b)(6) 2015 ct scan shows the subcutaneous tissue surrounding the catheter." she was also asked if she had any information on the prior implanted hero since this was the second time this occurred to this patient, her reply was, "this was the same hero, area had been debrided and buried deeper." the surgeon was asked if she had any insight as to why the titanium connector was eroding through the skin, if possibly something the patient was doing could have led to the issue, her response was, "(b)(6), also patient is active individual who does workout at gym, potentially partial erosion secondary to movement but this was buried in the pectoralis muscle." the surgeon also advised that the revision was not completed yet.Multiple attempts were made to obtain further information from the original implanting surgeon.An email and letters were sent asking for the lot number and date of implant, along with pertinent patient co-morbidities and operative notes if available.No response was received.Manufacturing records could not be reviewed as lot numbers for the hero device are unknown.A query for potential lot numbers could not be performed as the date of implant and implanting hospital are also unknown.A review of the available information was performed.The exact date of hero graft implant in this case was not known; however, the reporting surgeon stated the record indicates it was in (b)(6) of 2015 and was implanted by a different surgeon.The patient presented with the hero graft titanium connector exposed.It was reported that this patient had a similar event happen previously.The first event was treated with debridement and the surgeon buried the connector deeper (into the pectoralis muscle).It was also documented that the first time the erosion was documented in the record was on a ct scan on (b)(6) 2015, which showed "the subcutaneous tissue surrounding the catheter." the surgeon planned on revising the hero graft after the second presentation but the revision was not completed at the time the information was gathered.Additional information regarding specific patient history includes that the patient was (b)(6) and the patient was known to be an "active individual who does workout at gym." it is presumed that "(b)(6)" refers to a previous (b)(6) nasal swab indicating colonization with (b)(6) rather than an active infection since there was no mention of infection in the information provided.When asked to provide insight into why the erosion may have happened, the surgeon stated, "potentially partial erosion secondary to movement but this was buried in pectoralis muscle." the hero graft instructions for use (ifu) lists abnormal healing/skin erosion as a potential vascular graft and catheter complication.No additional information was provided including additional patient medical history and implant/intervention operative notes.In this case, the patient has a history of abnormal healing with the hero graft, history of (b)(6) and was reported to live an active lifestyle which may have increased the risk of erosion secondary to increased movement.The ifu provides the following instructions: "implantation of the hero graft is contraindicated if: the patient has a topical or subcutaneous infection associated with the implantation site; the patient has known or suspected systemic infection, bacteremia or septicemia.Obtain screening blood cultures to rule out asymptomatic bacteremia prior to hero graft implant for any patient dialyzing on a catheter; treat patient with antibiotics per culture outcome and ensure infection is resolved prior to hero graft implant procedure.Plan for increased bacteremia risk after an ipsilateral hero graft placement or with femoral bridging catheters and treat prophylactically with antibiotics knowing patients are at higher infection risk.Prophylactically treat the patient in the peri-operative period with antibiotics based on the patient's bacteremia history." the ifu lists the following potential complications with the use of the hero graft: infection, abnormal healing/skin erosion.
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