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According to the report, a hero "patient was implanted with a hero graft on (b)(6) 2006.Per the implant form, the patient suffered from major bleeding that required a blood transfusion on (b)(6) 2006.Per the 6-month follow-up form, the patient was hospitalized for weeping syndrome and had arm drained in or on (b)(6) 2006.Per the 18 month follow-up form, the patient was hospitalized for a gi bleed after ir procedure on (b)(6) 2007.On this same form, the patient was documented to have 3 percutaneous thrombectomies and one open thrombectomy from (b)(6) 2007, with flow restored in all events.This form also documents patient death on (b)(6) 2007.Cause of death is currently unknown." additional information is pending.According to the report submitted by (b)(6) has entered 64 informed consent forms in the hero registry for duke hero graft patients who have passed away and were recruited with a decedent waiver.Data will be reviewed as the coordinators enter the crfs associated with these patients." according to the initial report, the clinical study coordinator has entered 55 informed consent forms in the clinical study for hero graft patients who "have passed away and were recruited with a decedent waivers [inclusion into the study post mortem]".Additional information from the clinical site includes the following: implanted with initial hero on (b)(6) 2008, received thrombectomies on (b)(6) 2009 , experienced pe and wound infection on (b)(6) 2009, experienced bactermic event on (b)(6) 2009 bacteriama with intermittent events until 2010.The hero was explanted on (b)(6) 2010.Implanted with second hero on (b)(6) 2010, fever and pneumonia - (b)(6) 2010, infected hero - (b)(6) 2011, bacteremia - (b)(6) 2011, clotted hero - (b)(6) 2011, thrombectomy - (b)(6) 2011, thrombosed hero - (b)(6) 2011, thrombectomy - (b)(6) 2012, sepsis - (b)(6) 2012, thrombectomy - (b)(6) 2012, migration of hero - (b)(6) 2012, surgical revision - (b)(6) 2012, infected hero - (b)(6) 2012, hero explanted - death on (b)(6) 2014.This investigation is for patient (b)(6).The scope of the investigation will include both hero 1001 and 1002 components, but will be reported under hero 1001.
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The patient had a hero graft implanted on (b)(6) 2008.Following the first implant the patient was hospitalized with chest pain, had four cases of thrombosis requiring intervention, one pulmonary embolism, and four instances of infection/bacteremia/sepsis.This graft was explanted on (b)(6) 2010.A second hero graft was implanted on (b)(6) 2010.Following this implant, the patient was hospitalized with fever/pneumonia, had four cases on thrombosis requiring interventions, six cases of infection/bacteremia/sepsis, and two cases of device migration.This graft was explanted on (b)(6) 2012.The patient passed away on (b)(6) 2014 from events unrelated to the explanted hero from 2012.The manufacturing records for lots 0000134, 0001260, and 0001269 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.Patient was implanted with his first hero graft on (b)(6) 2008.The graft was implanted with a brachial anastomosis and the venous access point was the external jugular.The first date of cannulation is unknown, but occurred at some point in 2008.This patient was implanted with his second hero graft on (b)(6) 2010.The graft was implanted with a femoral arterial anastomosis and the venous access point was the iliac vein.The first cannulation date was in (b)(6) 2010.The patient's pre-existing medical conditions include the following: end stage renal disease (congenital ureteral obstruction), failed kidney transplant, atrial fibrillation, hypertension, gastroesophageal reflux, and pulmonary embolism (pe).The patient was also known to be on coumadin and plavix.The patient experienced non-cardiac chest pain in (b)(6) 2008 and was hospitalized.The ekg was normal and cardiac enzymes were negative.Warfarin therapy without heparin bridging was initiated due to the patient's history of atrial fibrillation.The hero graft did not have any reported involvement in this event.The patient experienced his first thrombosis event with the first implanted hero graft on (b)(6) 2009; between (b)(6) 2009 and (b)(6) 2009 the patient required four percutaneous/open thrombectomies (with and without tpa infusion) for thromboses in the first graft.The patient experienced his first thrombosis event with the second hero graft on (b)(6) 2011; between (b)(6) 2011 and (b)(6) 2012 the patient required three percutaneous thrombectomies for thromboses in the second graft.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).Thrombosis is the most common cause of vascular access dysfunction.Missed hemodialysis sessions significantly increase the number of thrombosis episodes in arteriovenous grafts (avgs).Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Intervention notes were provided.The surgeon administered tpa concurrently with thrombectomy procedures, as recommended in the hero graft fqa-explant, exchange, revision, or abandonment document.The patient's compliance with dialysis treatment is unknown and coumadin and plavix prescriptions appeared to be poorly controlled throughout the hero graft periods.Given the patient's complex medical history and unknown risk factors, the relationship between the hero graft and the repeated thrombectomies cannot be determined.The patient was hospitalized with angioedema from a shellfish allergy and a nonfunctioning hero graft in (b)(6) 2009.The patient had facial swelling, associated shortness of breath and difficulty swallowing.He was treated with racemic epinephrine, subcutaneous epinephrine, benadryl, ranitidine, and solu-medrol.He had a thrombectomy procedure a week before this event, however it was noted that he was dialyzed to his normal dialysis prescription and no hero intervention was identified in the admission note.Therefore, the hero graft did not have any reported involvement in this event.The patient was hospitalized in (b)(6) 2009 for chest pain/dyspnea that was associated with a high probability of pe (pulmonary embolism) (based on v/q scan), given the patient's history of pe and hypercoagulability state with the clotting of his grafts, he was treated with a heparin drip.The admission note documented that "it is possible that the source of the clot may have been the dialysis catheter" [permanent dialysis catheter was placed in (b)(6) 2009 when the hero graft clotted].It was also documented that the patient had been nontherapeutic (with coumadin) for a considerable amount of time.Pe was also noted as a secondary diagnosis in a hospital discharge summary in (b)(6) 2009; he was transitioned to his home coumadin prior to discharge.The hero graft ifu lists embolism as a potential intraoperative and postoperative complication.Given the presence of the perm catheter and the patient's past history of pe it is not possible to determine the specific relationship between the hero graft and the "probable pe." the patient had a recurrent issue with infection during the time of both hero graft implants; there were four documented events during the first graft period and six documented events during the second graft period.In (b)(6) 2009 the patient was hospitalized with a left upper extremity wound infection/cellulitis which was described as "an apparent wound dehiscence with mild infection overlying the graft." blood cultures were negative and his white blood count was relatively normal, but he was treated with vancomycin and gentamicin for one week, as well as local wound care with betadine swabs and dressing changes.The reported infection appears consistent with a surgical site infection associated with a recent open thrombectomy procedure performed in (b)(6) 2009.In (b)(6) 2009 the patient was hospitalized with staph coagulase-negative bacteremia and sepsis; he developed thrombocytopenia, as a result of his aforementioned state.The patient's permcath was subsequently removed when he was no longer bacteremic and was replaced with a permcath in his right groin.At this point the hero graft was described as nonfunctional and was abandoned.Of note, the site of his av graft "did not show any signs of infection." he was treated with vancomycin again.A discharge summary in (b)(6) 2009 stated the patient was found to have (b)(6) bacteremia during the (b)(6) visit; this was not confirmed in the (b)(6) discharge note.In (b)(6) the patient presented with coagulase-negative staphylococcal bacteremia and a permcath infection.In the discharge summary the "hero graft was thought to be a possible source of infection in addition to the groin permcath, however, had no ultrasonographic evidence of associated abscess." his physical examination in the (b)(6) admission showed swelling, erythema, and fluctuance around the right groin permcath.The source was presumed to be the right groin permcath; it was replaced with a left common femoral vein permcath and he was treated with vancomycin for 6 weeks.In (b)(6) 2010 the patient presented with his fourth infection since the first hero graft; he presented with coagulase-negative staphylococcal catheter associated sepsis and thrombocytopenia again.The patient also reported pain, swelling, and increased temperature around the hero graft.He denied any tenderness, drainage, or purulence at the permcath site.Cultures on (b)(6) 2010 were positive and the patient's left groin permcath was removed and a right femoral permcath was placed on (b)(6) 2010.He was again treated with vancomycin.In (b)(6) 2010 the hero graft was explanted, as it was deemed "chronically infected." at the time of explant, the patient also had a left shoulder abscess that was drained.There was evidence of infection at the level of the graft; the area was irrigated with antibiotics and bacitracin soaked gauze was placed around the wound.The results of the cultures from the explant are unknown.Since the hero graft was not in use at this time, the most likely explanation is a chronic secondary infection resulting from multiple episodes of bacteremia related to the permcath.The first event of possible infection following the second hero graft implant occurred in (b)(6) 2010 when the patient was hospitalized with fever and pneumonia.No additional information was provided about this hospital visit.Therefore, the source of the fever and potential culture results are not currently known.In (b)(6) 2010, about 5 months after implant, the patient was admitted with a fluctuant mass overlying the outflow portion of his left groin hero graft.The cultures revealed (b)(6).The patient went into surgery for incision and drainage.At this point it was noted that the distal portion of the arterial graft component (agc) was poorly incorporated, suggesting infection around the graft.Given the patient's limited vascular access options, the surgeon chose to attempt hero graft salvage one last time with extensive antibiotic treatment with a slurry of tisseel and vancomycin and surgical packing with betadine soaked gauze.In (b)(6) 2011 the patient was hospitalized again for gram positive cocci bacteremia.The patient presented with a small pustule over the superior portion of his hero graft, which was about 4mm wide with a small amount of draining pus (which did not require drainage or other intervention).At this time the patient was sent home with a "wound vac to his left groin, as well as vancomycin, gentamicin, and rifampin." in (b)(6) 2012 the patient presented with sepsis with coagulase-negative staphylococcus bactermia.The previous abscess associated with the hero graft was presumed to be the source of the infection; ultrasound revealed several hypoechoic complex collections adjacent and medial to the graft which were also noted on a recent ct of the abdomen/pelvis.The patient was given vancomycin, as well as piperacillin/tazobactam.In (b)(6) 2012 the patient presented with "infection of left groin coupler hero graft." the "coupler device" and agc was partially replaced and debridement of the infection was completed.Culture results were not provided at this visit.A few weeks later the patient was hospitalized with sepsis (secondary to proteus mirabilis bacteremia), acute respiratory failure (secondary to septic shock) and an infection of the hero graft.The second hero was explanted.The hero graft ifu lists infection, wound dehiscence, and abnormal healing/skin erosion as potential vascular graft and catheter complications.In addition, the ifu lists sepsis as a potential intraoperative and postoperative 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; in this case the patient was treated with antibiotics post implantations.Primary infection directly caused by a hero graft is unlikely since the device undergoes a validated sterilization process.More likely causes of secondary infection include surgical site infection or infection related to cannulation.As previously stated, the source of a majority of the infections was permcath related.The hero graft ifu suggests removing the bridging catheter as soon as possible once the hero graft is ready to be cannulated to decrease the risk of an infection related to the bridging catheter.Given the complex patient history, co-existence of the permanent catheters, and the validated hero graft sterilization process the relationship between the hero grafts and the reoccurring infections cannot be determined.The patient had multiple issues with uncontrolled hypertension and atrial fibrillation throughout both hero graft implant periods.The patient had a pre-existing medical history of hypertension and atrial fibrillation; therefore, these events are not related to the hero graft.The patient had an issue with pseudoaneurysms, which was first noted in a (b)(6) 2011 discharge summary.An ultrasound of the second femoral hero graft identified "heterogeneous increased echogenic structure with doppler flow, likely representing a thrombosed previously identified pseudoaneurysm." pseudoaneurysm is listed on the hero graft ifu as potential vascular graft and catheter complications.As stated in the ifu, rotation of cannulation sites is needed to avoid pseudoaneurysm formation.Cannulation information from the dialysis clinic is currently unavailable.The specific relationship between the hero graft and the pseudoaneurysm cannot be assessed at this time without additional information.In (b)(6) 2009 the patient was reported to have nausea and vomiting.The symptoms were attributed to the narcotics the patient was administered for his co-existing issues; therefore, the nausea and vomiting is not related to the hero graft.In (b)(6) 2010 the patient presented with left shoulder pain secondary to hero graft site.A left upper extremity ultrasound showed "a complex fluid collection adjacent to the patient's hemodialysis graft in the proximal left shoulder region." the differential diagnosis included seroma vs.Lymphocele vs.Hematoma vs.Abscess.Seroma and hematoma are both listed in the hero ifu as potential vascular graft and catheter complication.No additional information was available, but of note the patient had coexisting gram positive cocci resembling staph at the time the fluid collection was identified.Given the complex patient history and coexisting infection, the relationship between the hero graft and unspecified fluid collection cannot be determined.On (b)(6) 2012 the patient's second hero graft migrated; the graft was abutting the tricuspid valve, causing severe tricuspid regurgitation.At this time, the venous outflow component (voc) was retracted, the "coupler device" was replaced and the graft was partially replaced.Device migration is listed as a potential vascular and catheter complication.Directions on how to place the graft are provided in the ifu.The operative note for the second implant confirmed that "imaging confirmed appropriate positioning of all components." it is unclear at what point the voc migrated, given the two year time lapse between implant and migration.The provided notes did not disclose potential causes for hero graft migration.Given the complex patient history and coexisting medical issues, the relationship between the hero graft and how the device migration occurred cannot be determined.In (b)(6) 2012 the patient presented with right heart failure, evidence of cardiomegaly, severe pulmonary hypertension, and right ventricular dilatation and dysfunction.The presentation was attributed to acute-on-chronic pulmonary emboli; there was no documented relationship between these events and the hero graft.Both hero grafts were explanted secondary to systemic infection, as previously described.The first implant was explanted on (b)(6) 2010 and the second implant was explanted on (b)(6) 2012.Revisions failed and the infection continued to reoccur; in these situations explant was deemed necessary.The patient died on (b)(6) 2014, more than two years after hero graft explant.The patient was admitted to the icu for a prolonged period of time before his death with the following issues: severe pulmonary hypertension, sepsis (no known source), chest pain, ischemic foot, pulmonary embolism, gangrene/lower limb ischemia (requiring bilateral lower knee amputation), nonhealing bed sores, and severe pain.There is no alleged relationship between the hero graft and the patient's death; the patient had a complex medical history and multiple serious conditions at time of death.The hero graft was clinically evaluated in subjects with upper arm implants and venous access through the internal jugular vein.Clinical outcomes with the hero graft using the external jugular vein and grafts in the femoral placement have not been evaluated by cryolife.The ifu states "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", "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication", and "use of the hero graft was clinically studied utilizing the internal jugular vein.Central venous access through any other veins, for example, the subclavian vein, has not been studied and may increase the risk of adverse events not encountered in the clinical trial." the patient had a very long and complicated medical history.Several of the hospital admissions were unrelated to the hero graft.The ifu lists the following potential complications: infection, sepsis, anastomosis or wound dehiscence, abnormal healing/skin erosion, vascular graft revision/ replacement, partial stenosis or full occlusion of prosthesis or vasculature, site pain, device migration, pseudoaneurysm, seroma, hematoma, embolism, or death.The patient's deteriorating health and complicated medical history contributed to his death.The patient passed away more than 2 years after explant of the hero graft from events unrelated to the hero graft.
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