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According to the initial report, hero patient (b)(6) died on (b)(6) 2015.Cause of death "appears to be pea [pulseless electrical activity], most likely 2/2 hypoxia" according to the hospital.Additional information received indicated a complicated history of thrombosis, occlusion, and ongoing infection prior to death.Case report forms (crfs) and pre-operative imaging/operative notes were provided on (b)(6) 2015.On 09/29/2015, additional information was received via email from the rep that stated, "this patient had 2 hero graft implants, one on (b)(6) 2008 and one in 2015 (already reported).This form documents infection (not bacteremia) during hero graft implant period." the infection event is addressed in a forwarded email from (b)(6) 2015, between her and the clinical site.It includes the following information provided by the clinical site regarding the recorded infection event: the infection was documented on "(b)(6) 2008," "no blood cultures were drawn," "there is only one lot number, it is documented as a hero kit [recorded as hero 1001, lot 10020980]," and the infection was "local" and "related to implant procedure." the first hero graft, left femoral venous outflow component (voc, hero 1001, lot 10020980) was implanted on (b)(6) 2008.A local surgical site infection was noted at "inferior most portion of arterial wound" on 2008.The patient was "started on keflex prior to discharge for slight peri-incisional suspected infection." the patient returned to the clinic on (b)(6) 2008 with a "local wound infection after graft cath placement.He will continue on oral antibiotics and local wound care." the infection was treated and released for use on (b)(6) 2008.Magnetic resonance imaging (mri) from (b)(6) 2015 was indicated for "mechanical complication of other vascular device, implant, and graft" of other implanted upper extremity catheters and revealed superior vena cava (svc) obstruction.As a result, surgical intervention was planned for the patient.The pre-operative diagnosis on (b)(6) 2015 stated central venous occlusion (cvo), renal failure, and infected left thigh hero graft.The following operation was performed: removal of existing central venous catheter, central venogram with interpretation and evaluation of the svc, balloon angioplasty of subclavian/brachiocephalic vein and svc, placement of left upper extremity hero graft via central venous catheter exchange using the axillary artery for inflow, and excision of infected left thigh hero graft.Hospital notes from (b)(6) 2015 state "patient expired from pea arrest most likely 2/2 hypoxia while on the way to his room in the icu." the patient history leading up to this event is recorded as the following: "(b)(6) male w/ pmh [past medical history] of bipolar disorder, depression, polysubstance dependence (alcohol, cocaine), obesity, htn [hypertension], hfpef [heart failure with preserved ejection fraction], esrd on hd mwf [hemodialysis on monday, wednesday, friday] c/b [complicated by] extremely poor access s/p [status post] left bka [below knee amputation] and recent admission to (b)(6) hospital (b)(6) 2015 & (b)(6) 2015 for (b)(6] septicemia thought to be 2/2 infected, clotted hero graft s/p hero graft replacement, with hospital course c/b torsades/pea arrest requiring compressions/shock/epi and ugib [upper gastrointestinal bleed] 2/2 downhill esophageal varices s/p 2 units prbc (packed red blood cells), related to svc thrombus." on (b)(6) 2015 the patient was returned to the hospital via ems with respiratory distress, unresponsiveness, bradycardia, hypoglycemia, and hypovolemia.Once in icu, code blue called for pea arrest and "after 24 minutes of cpr, patient was pronounced at 16:39 on (b)(6)." medical notes and crfs indicate a patient medical history of the following: end-stage renal disease (esrd), "multiple bilateral upper extremity hemodialysis access procedures over 13 years, all of which have failed and led to bilateral upper extremity exclusions negating his upper extremities or chest from any further access attempts," history of bacteremia, peripheral vascular disease (pvd), polysubstance abuse, bipolar disorder, hypertension, asthma, hyperparathyroidism, and smoking.The manufacturing records for the first hero graft implant (lot 10020980) were not reviewed as this was not an actual lot number produced at the time.The clinical site coordinator indicated to the rep that this was the only lot recorded.The manufacturing records for lots h15vc011 and h15av001 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.This hero registry patient was implanted with his first hero graft on (b)(6) 2008 via a femoral placement.The first date of cannulation was (b)(6) 2008.A second hero graft was implanted on (b)(6) 2015 with axillary anastomosis and venous access point at the internal jugular vein.The first cannulation date is unknown.The patient's pre-existing medical conditions include the following: esrd, pvd, hypertension, bacteremia, chronic obstructive pulmonary disease (copd), and ventricular fibrillation.The patient was also known to be on coumadin.Following the first hero graft implant, the patient presented with a local surgical site infection at "inferior most portion of arterial wound" on (b)(6) 2008.The source of the infection was documented as "related to the implant procedure".The patient was treated with keflex.Blood culture results were not provided.On (b)(6) 2008 the patient presented with the same local wound infection; he had "some drainage from his thigh wound for the last several days and denies fevers or chills." he was treated with continued oral antibiotics and local wound care.He was dialyzing with a permanent catheter during the infection period.This infection completely resolved by (b)(6) 2008.There was no record of infection from (b)(6)2008 to (b)(6) 2015.The patient was hospitalized on (b)(6) 2015 for unresponsive hypoglycemia and hypotension associated with septic shock, bacteremia, and infected left thigh hero (b)(6).The source of infection was presumed to be the hero graft, which had clotted and was s/p thrombectomy performed on (b)(6) 2015.The patient was treated with vancomycin and gentamicin and was later "narrowed to cefazolin to complete a 14 day course." given the time frame between implant and the reported infection/sepsis, it is unlikely that the hero graft was the primary source of infection.If the hero graft was involved, then it was likely secondary infection of the graft related to cannulation.Following the second hero graft implant, the patient was admitted on (b)(6) 2015 "with altered mental status, found unresponsive with hr 40, glucose <20 with no measurable bp [blood pressure], brought to ed [emergency department], now intubated but unresponsive." the patient was reported to have "sepsis and infected access s/p (b)(6) septic shock due to infected leg access, resected." of note the patient's blood cultures were reported to be (b)(6) since (b)(6) 2015.However, on (b)(6) 2015 "his tissue had rare growth of (b)(6)." the implant operative note stated "there was no purulence or gross evidence of infection" during the explant of the original hero graft.It is unclear if the patient had an active infection at time of second implant.The hero graft instructions for use (ifu) lists infection as a potential vascular graft and catheter complication.In addition, the ifu lists sepsis as a potential intraoperative and post-operative 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.Cultures of the excised hero graft show growth of (b)(6) indicating that the preexisting local infection had not completely resolved at the time of explant of the first graft and the implant of the second graft.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 implantation.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.The patient had a perm cath during both hero graft implants and it cannot be ruled out as a possible source of the infection events.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.The patient also had a prior history of bacteremia; specific information regarding past infections, including culture results, were not provided.Given the complex patient history and coexistence of the permanent catheters, the relationship between the hero grafts and the reoccurring infection/sepsis cannot be determined.The patient's first hero graft "required numerous attempts at un-clotting, including multiple attempts to unclot it at carolina access, which may have seeded the graft." the first thrombosis event, with documentation provided, was on (b)(6) 2015 when a thrombectomy was performed.There is no additional information available on previous thrombosis events or interventions to treat occlusion between (b)(6) 2008 and (b)(6) 2015.The hero graft was also described as occluded in a discharge summary note in early (b)(6) 2015.The description included, "the ivc [inferior vena cava] is occluded at the tip of the graft.There is a filling defect in the inferior ivc adjacent to the graft, likely thrombus.The left common iliac vein, external iliac vein, and common femoral vein are stenosed around the graft.The right external iliac vein is occluded.There is a filling defect in the right common femoral vein and distal right femoral vein, likely thrombus." an intervention was not attempted at that point.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).Hypercoagulable states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The patient's compliance with dialysis treatment and warfarin prescription is currently unknown.Given the patient's complex medical history and unknown risk factors, the relationship between the hero graft and the repeated clotting issues cannot be determined.On (b)(6) 2015, the patient developed a gastrointestinal bleed (gi) and downhill esophageal varices following heparin treatment during multiple surgical procedures.He was treated with octreotide and was transitioned to pantoprazole.The gi bleed was likely related to the administration of heparin and the varices were caused by pre-existing superior vena cava occlusion; the second hero graft was not implanted until four days after the gi bleed/varices were first reported.The first hero graft was implanted in the femoral placement and could not have had any involvement in this event.Throughout the hero graft implants, the patient had issues with hypertension.As previously stated, he had a prior medical history of hypertension.Notably, the patient had issues with hypertension during the hospital stay prior to his second hero graft implant surgery; he also had ventricular tachycardia (vt) with torsades and pea arrest, which required advanced cardiac life support (acls).It was unclear what caused the torsades and pea, but it was potentially attributed to electrolyte abnormalities or hypoglycemia.The patient's pre-existing cardiac conditions (notably hypertension and ventricular fibrillation) are risk factors for these aforementioned events; the hero graft had no documented involvement in the reported hypertension, vt, torsades, or pea.The first hero graft was explanted on (b)(6) 2015 secondary to infection, as previously described.Revisions failed and the infection continued to recur.The patient died on (b)(6) 2015, a few weeks after the second hero graft implant.The cause of death "appears to be pea, most likely 2/2 hypoxia." death is listed in the hero graft ifu as a potential intraoperative and post-operative complication.The relationship between the hero graft and the patient's death is unknown; the patient had a complex medical history and multiple serious conditions, all of which placed the patient at high risk for sudden cardiac 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 grafts in the femoral placement have not been evaluated by cryolife.
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