|
According to the report "hero registry patient was implanted with the hero graft on (b)(6) 2014.On (b)(6) 2014 the patient was hospitalized with "afib with rvr" [atrial fibrillation with rapid ventricular rate].On (b)(6) 2014 the patient was hospitalized with afib and infection.On (b)(6) 2015 the patient was hospitalized with volume overload.On (b)(6) 2015 the patient was hospitalized with infection/sepsis." the manufacturing records for lots h14av022 and h14vc045 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.This hero registry patient was implanted with a hero graft on (b)(6) 2014.The graft was implanted with a brachial anastomosis and the venous access point was the internal jugular.The first date of cannulation occurred in (b)(6) 2015 (sometime after (b)(6) 2015); during the incorporation period the patient dialyzed with a right femoral perm cath.The patient's pre-existing medical conditions include the following: coronary artery disease, hypotension, paroxysmal atrial fibrillation, diastolic congestive heart failure, diabetes mellitus type ii, crohn's disease, and end stage renal disease.The patient also has a jackson-pratt (jp) drain due to multiple episodes of biliary sepsis and is on chronic prednisone.The patient was admitted to the hospital on (b)(6) 2014 with afib with rvr.Preliminary diagnostics (ct scan) also indicated "diffuse interstitial opacities, favoring mild pulmonary edema with small right pleural effusion." the patient reported a history of difficult to control international normalized ratio (inr) and was not currently on anticoagulation despite cha2ds2-vas score of 5.The patient was on clopidogrel after hero implant surgery, which was intended for 6 weeks.The patient was referred to cardiologist to discuss the risks and benefits of anticoagulation in a setting of anti-platelet therapy and a primary care physician for consideration of further imaging (to follow-up on abnormal ct scan).The hero graft was never implicated as a potential source of the afib or pulmonary edema.The hero graft instructions for use (ifu) lists cardiac arrhythmia and edema as potential intra-operative and post-operative complications and potential vascular graft and catheter complications, respectively.However, there was no documented relationship between the reported afib and pulmonary edema and the hero graft.The patient's anticoagulation and anti-platelet therapies, as well as pertinent cardiac medical history, were the focus of treating the reported events.The patient was admitted to the hospital again on (b)(6) 2014 for afib, fever, and sepsis.The patient's fever and associated symptoms were consistent with systemic inflammatory response syndrome (sirs)/sepsis.He was treated "with vancomycin and zosyn, then vancomycin and cefepime." the blood cultures at discharge showed no growth and the perc bili [percutaneous biliary] fluid looked clear; blood cultures were reportedly negative, per future visit notes.The source of the infection was not identified.The hero graft ifu lists infection as a potential complication.Infection is a known complication of prosthetic arteriovenous (av) grafts.The patient selection considerations listed in the hero graft ifu states the patient should be screened for infection and ensure infection is resolved prior to hero graft implant procedure.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.Primary infection directly caused by a hero graft is unlikely since the device undergoes a validated sterilization process; a cannulation site infection was also not possible because the graft was not cannulated yet.The patient was dialyzing with a femoral perm cath.The pulmonary nodules found on the ct from the prior visit remained under observation during this visit.Regarding the afib, metoprolol was held during acute illness and resumed prior to discharge after fluid resuscitation.As previously stated in the prior afib event, there was no documented relationship between the event and the hero graft.The source of the infection was not documented and with the provided information, the relationship between the infection and the hero graft cannot be determined.The patient was admitted to the hospital again on (b)(6) 2015.The patient presented with shortness of breath and chf, "unspecified failure chronicity." the patient had volume overload "due to ivf [intravenous fluids] from recent hospitalizations and limited uf [urine flow]." the patient appeared to have pulmonary edema and required volume removal.He was to continue on metoprolol and amiodarone for his afib.The source of the shortness of breath was not clearly identified; the pulmonary edema would most likely have had an impact on his breathing.As previously stated in the prior afib event, there was no documented relationship between the event and the hero graft.The patient has pre-existing chf, which likely played a role in this patient's repeated hospitalization post-implant.There was no reported relationship between the hero graft and these events.The patient had no reported adverse events until (b)(6) 2015 when he presented with sepsis (with shock), septic encephalopathy, hyperkalemia, and afib with rvr.Imaging also identified a small left pleural effusion.Cultures obtained at another emergency department from a few days earlier reported negative cultures.Cultures from this visit grew out enterobacter aerogenes from bile.His antibiotics were changed to cipro; however he required pressors for several days.The source of the sepsis was the biliary tract.The patient has a history of a chronic cholecystectomy tube because of chronic calculous cholecystitis.With the provided information, there is no relationship between the infection and the hero graft.The relationship between the pleural effusion and the hero graft cannot be determined with the information provided.In conclusion, the hero graft had no reported involvement with the patient's afib events.The source of the septic event on (b)(6) 2014 was not documented and culture results were negative.The infection in (b)(6) 2015 was related to the biliary tract and is supported by the presence of a gram negative enteric organism.The volume overload the patient experienced was a direct result of end stage renal disease and the hero graft had no direct involvement in this issue.The patient suffered from pulmonary edema, pleural effusion, and shortness of breath, all are consistent with chf and are not likely related to the hero graft.The ifu provides the following information: "do not use product if package has been damaged, opened, or the use by date has passed, as sterility may be compromised," and "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 screen 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 infection, sepsis, edema, and cardiac arrhythmia as potential complications associated with the use of the hero graft.
|
