|
The patient had a hero graft (lot number 10021160; 10014308) implanted on (b)(6) 2008.On (b)(6) 2008 the patient was admitted to the hospital and underwent a kidney transplant.On (b)(6) 2008 she suffered a wound dehiscence.On (b)(6) 2008 she was hospitalized for acute rejection of his kidney transplant.According to the 6 month follow-up crf she was treated for an infection from an unknown source in (b)(6) 2008.She was hospitalized on (b)(6) 2009 for chf (congestive heart failure) exacerbation.On (b)(6) 2009 she was admitted for a fib (atrial fibrillation) with rvr (rapid ventricular rate).On (b)(6) 2009 she was hospitalized for an infection of her permcath.On (b)(6) 2009 the patient's hero was fully occluded and explanted.On (b)(6) 2010 her first hero was explanted and a second hero (lot number 0001190; 0001192) was implanted.The patient's second hero graft occluded three times; percutaneous thrombectomies were done on (b)(6) 2010, (b)(6) 2010, and (b)(6) 2010 after which flow was restored on all three occasions.On (b)(6) 2010 the patient was admitted for a right groin permcath infection and persistent bacteremia.There were also concerns that the patient could have possibly had a stroke.A ct scan was obtained but revealed no signs of acute intracranial hemorrhage.As the patient had a history of permcath infections it was thought that her symptoms were secondary to infection rather than a focal neurologic event.She had severe rigors with dialysis; therefore, the permcath was removed.The patient then became tachycardic and her blood pressure dropped.Supportive care was continued on (b)(6) 2010 and (b)(6) 2010.Several blood culture results showed staph aureus.An mri was done on (b)(6) 2010 as the patient complained of buttock pain to rule out vertebral osteo and epidural abscess.While the patient was in mri she became unresponsive.The initial rhythm was pea (pulseless electrical activity).Resuscitation efforts lasted approximately 50 minutes, however were unsuccessful and the patient was pronounced dead at 10:36am.The manufacturing records were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.This patient was implanted with two hero grafts.The first hero graft was implanted on (b)(6) 2008.The graft was implanted with an arterial anastomosis and the venous access point was an axillary vein.The first date of cannulation was unknown; however, the first documentation that the hero graft was used for dialysis was on (b)(6) 2009.The patient had a kidney transplant on (b)(6) 2008, which delayed the need for dialysis access.The patient suffered from acute kidney rejection in (b)(6) 2008.The second hero graft was implanted on (b)(6) 2010.The graft was implanted with an arterial anastomosis and the venous access point was a subclavian vein.The first date of cannulation was in (b)(6) 2010 (sometime after (b)(6) 2010).The patient's pre-existing medical conditions include the following: multiple failed attempts at dialysis access, polycystic kidney disease, hypertension, a fib, chf, coronary artery disease (cad), mitral regurgitation, anemia, gastroesophageal reflux, diabetes mellitus type ii, hypothyroidism, and end stage renal disease.The patient had a history of chronic steroid use and history of warfarin therapy.The patient had a history of access related bacteremia and infection and had multiple infection events after both hero graft implants.There were two infection events during the first hero implant period.The 6 moth follow-up crf for the first implant also reports a wound dehiscence event on (b)(6) 2008.There was no additional information provided to determine the source/location of the wound; however, the patient underwent a kidney transplant approximately three weeks earlier.On the same follow-up form the patient had a documented infection in (b)(6) 2008; blood cultures were reported to be positive for corynebacterium.The source of the infection was unknown and no additional information was provided.The 12 month follow-up crf for the first implant reports another infection event on (b)(6) 2009, which was diagnosed as permcath bacteremia with blood culture results where the organism was identified as "gram+rods." at this time the patient was reported to be on vancomycin.The source documents were not provided.The blood culture positive for corynebacterium likely represents culture contamination by skin flora.It should be noted that the patient was receiving immunosuppressive therapy for the kidney transplant at the time of the reported positive blood culture in (b)(6) 2008.There was one documented event of bacteremia during the second hero implant period.On (b)(6) 2010 the patient was admitted with a right groin permcath infection and persistent bacteremia.The patient was symptomatic with reported fever, rigors, leukocytosis, thrombocytopenia and was treated with vancomycin and the permcath was explanted and replaced with a vas cath.Blood culture results came back repeatedly (b)(6) for (b)(6) despite antibiotic treatment.All cases of infection in the patient appear to be related to the permcaths and the case of wound dehiscence may have been a surgical site infection post-kidney transplant; there is no documentation to support the hero graft's involvement in the events.However, the hero graft instructions for use (ifu) lists infection and wound dehiscence as potential complications.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.More likely causes of secondary infection include surgical site infection or infection related to cannulation.The patient had a history of cardiac problems, including chf, a fib, cad, and mitral regurgitation.The patient had two cardiac events during the first hero implant period.The 6 month follow-up crf for the first implant reports that on (b)(6) 2009 the patient had "chf exacerbation" which indicated "possible rejection" post-kidney transplant on (b)(6) 2008.The same form reports an a fib with rvr event on (b)(6) 2009.The patient had one reported cardiac event during the second hero implant period.During the (b)(6) 2010 hospital stay the patient was reported to have a fib/flutter and was placed on heparin instead of coumadin due to her history of stroke.During the patient's permcath explant the patient became tachycardic with heart rates in the 130s and 150s.On (b)(6) 2010, the patient had a cardiogram which was significant for "left ventricular ef of greater than 55%, annular calcified mitral valve, thickened aortic valve, moderate mr and no valvular stenosis" and a small pericardial effusion was noted also.The patient was ordered to have another echocardiogram following mri; however the patient became unresponsive during the mri on (b)(6) 2008 and died.The patient had a pre-existing history of cardiac problems, which occurred throughout both hero graft implant periods.There was no reported relationship between the hero graft and the aforementioned cardiac events.The patient had repeated thrombosis events which required multiple interventions.The 12 month follow-up crf for the first implant reports that the hero was not being used for dialysis due to a clot in (b)(6) 2009.No additional information was provided, including intervention notes.Eventually the first implant was explanted on (b)(6) 2009 because the graft was fully occluded and the surgeon was unable to restore flow, even after the clot was removed.The surgical note stated that the graft "thrombosed for reasons which are unclear." there were three thrombosis/occlusion events during the second hero implant period.The patient required three percutaneous thrombectomies, (b)(6) 2010, (b)(6) 2010, and (b)(6) 2010.On (b)(6) 2010 the patient also required a stent graft placement.After the last percutaneous thrombectomy in (b)(6), the graft became nonfunctional.Partial stenosis or full occlusion of the prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).Hypercoagulability 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 was known to be on warfarin; however, the patient's medication compliance throughout both hero graft implant periods is unknown.During the (b)(6) 2010 hospital admission the patient was documented to be sub therapeutic on warfarin with an international normalized ratio (inr) of 1.5.Prosthesis failure listed in the hero ifu as a potential vascular graft and catheter complication.Regarding the explant of the first hero graft, the ifu also states: "the hero graft venous outflow component (voc) and connection portion should be removed if the device will not be used for hemodialysis access." given the patient's complex medical history, the relationship between the hero graft and the thrombosis/occlusion events cannot be determined at this time without additional information.The patient died on (b)(6) 2010.The patient had multiple complications surrounding the time of death.At the end of (b)(6) the patient was acidotic and hyperkalemic due to inadequate dialysis.After the right femoral permcath was placed, the patient developed a persistent permcath infection, which was previously described.During an mri to "rule out vertebral osteo and epidural abscess" the patient became nonresponsive, pulseless and apneic, and "initial rhythm was pea." the official cause of death was not documented.There was no reported relationship between the hero graft and the patient's death.The patient had a significant history of co-existing medical issues and uncontrolled bacteremia at the time of death.The ifu lists the following potential complications with the use of the hero graft: infection, anastomosis or wound dehiscence, vascular graft revision/replacement, partial stenosis or full occlusion of prosthesis or vasculature, prosthesis, and death.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 "administration of drugs such as tpa or urokinase to lyse the thrombus is recommended.".
|
