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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 operating room on 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 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 received includes the following: hero graft was implanted on (b)(6) 2008.The patient experience bacterimia on (b)(6) 2008 and thrombectomies on (b)(6) 2008 and (b)(6) 2009 for occlusive events.Medical/treatment course was complicated by recurrent gi bleeds((b)(6) 2012), prolonged qt interval on (b)(6) 2015, volume overload secondary to esrd on (b)(6) 2012, and sepsis on (b)(6) 2012.The patient died on (b)(6) 2012.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 was admitted on (b)(6) 2008 for bacteremia which was confirmed as klebsiella, enterococcus by blood cultures and the source was presumed to be access related.The infection resolved and the patient was discharged on (b)(6) 2008.The hero graft was noted to be fully occluded and percutaneous thrombectomies were performed on (b)(6)2008, (b)(6) 2008, and (b)(6) 2009; flow was restored following each intervention.On (b)(6)2012, the patient was admitted for an upper gi (gastrointestinal) bleed; the patient was discharged on (b)(6) 2012.Additional hospital admissions included (b)(6) 2012 for prolonged qt interval, (b)(6) 2012 for recurrent gi (b)(6) bleed, (b)(6) 2012 for volume overload secondary to end-stage renal disease (esrd), and (b)(6) 2012 for sepsis.Patient death was recorded as (b)(6) 2012; bacteremia was confirmed with blood cultures (coagulase-negative staphylococcus) and the presumed source of infection was listed as access related.A death summary was provided which stated "[the patient] was a (b)(6) year-old lady with end-stage renal disease, dialysis dependent for the previous 13 years she also had a history of congestive heart failure.She was admitted [on (b)(6) 2012] with persistent hypotension suspected due to sepsis.She subsequently developed multiorgan failure likely due to ischemic bowel.She had a persistent metabolic acidemia; required multiple pressors for blood pressure support and subsequently, after being extubated, had to be re-intubated.She was unresponsive on (b)(6) 2012.Her organ failure continued to profess and she subsequently died with family at the bedside, (b)(6) 2012 at 1925." the final diagnosis was listed as "sepsis with possible ischemic bowel." a review of manufacturing records could not be performed as the lot number provided by the site, 100209808a, was not a valid format of lot numbers.A review was performed of the available information.This hero registry patient was implanted with a hero graft on (b)(6) 2008.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) 2008 (sometime after (b)(6) 2008).The patient's pre-existing medical conditions include the following: end stage renal disease, diabetes mellitus type 2, hypertension, anemia, cardiac heart failure, peripheral vascular disease, and history of multiple graft placement failures.On (b)(6) 2008 the patient presented to the emergency room with fever, chills, and tachycardia.She was found to have bacteremia; blood cultures on (b)(6) 2008 returned positive for klebsiella.Blood cultures on (b)(6) 2008 returned positive for enterococcus.She received treatment with gentamicin and vancomycin.Cultures on (b)(6) 2008 showed no growth.Her right thigh permanent catheter was replaced on 09/30/2008 and she was discharged to receive gentamicin for two more weeks.The hero graft had no documented involvement in this episode of infection.There were no infection events documented from (b)(6) 2008 to (b)(6) 2012.In (b)(6)2012 the patient was h.Pylori antibody positive and at that time received treatment with macrolide and a proton pump inhibitor; the source of the h.Pylori was a duodenal ulcer.In (b)(6) 2012 the patient presented with sepsis with cultures that were positive for coagulase negative staph.The source of the sepsis was not documented in the death summary.The hero graft instructions for use (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; in this case the patient did receive prophylactic 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 or infection related to cannulation.In this case, the bacteremia in (b)(6) 2008 was attributed to the patient's perm cath.The cause of the sepsis in (b)(6) 2012 was not documented.In (b)(6) 2012 the hero graft was described as having no sign of infection; the hero graft was never implicated as a potential source of infection.The relationship between the reported infections and the hero graft cannot be determined without additional clarifying information.The patient had 3 occlusion events between (b)(6) 2008 and (b)(6) 2009, which required percutaneous thrombectomies ((b)(6)2008, (b)(6) 2008, and (b)(6) 2009).The hero graft was reported as fully occluded with flow restored post-intervention in all three cases.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft 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.As stated in the ifu, missed hemodialysis sessions significantly increase the number of thrombosis episodes in avfs and avgs.The patient had documented issues with volume overload which is often associated with inadequate dialysis.Additionally, the patient was known to be on plavix (compliance with prescription is unknown).The relationship between the hero graft and the occlusion events cannot be determined without additional clarifying information.On (b)(6) 2012 the patient was hospitalized for upper gi bleeding from a duodenal ulcer.She received 6 units of packed red blood cells and was placed on a protonix drip.The patient had a history of plavix use and baby aspirin; both were suspended until re-evaluation with primary care physician.On (b)(6) 2012 the patient was admitted for recurrent upper gi bleed.She was treated with a protonix drip and was placed on an oral proton pump inhibitor.There was no documented relationship between the gi bleed events and the hero graft.On (b)(6) 2012 the patient presented with lower extremity weakness and shortness of breath which were affiliated with prolonged qt interval and cardiac arrhythmia.The cause of the aforementioned cardiac events was the macrolide that the patient was prescribed as h.Pylori treatment.After medication discontinuation the patient's qt interval normalized and she was discharged.There was no documented relationship between these cardiac events and the hero graft.On (b)(6) 2012 the patient presented with volume overload, acute on chronic systolic congestive heart failure (chf), left bundle branch block with prolonged qtc, and anemia.Upon examination the patient was found to have bilateral pulmonary effusions (pe); her volume overload and pes began to resolve after she was dialyzed down to a dry weight of approximately 111kg.The patient had a history of chf and anemia.As previously stated, her new diagnosis of prolonged qt interval was attributed to treatment on macrolide.It is unclear if the patient missed a dialysis session or if her dialysis sessions were inadequate; dialysis information is not available.There was no documented relationship between chf, prolonged qtc, and anemia and the hero graft.The anemia may be related to the known clinical history of a duodenal ulcer caused by h.Pylori.The relationship between the volume overload and the hero graft cannot be determined without additional information.On (b)(6) 2012 the patient died with a final diagnosis of sepsis with possible ischemic bowel.On admission the patient had persistent hypotension and after admission the patient suffered multiorgan failure and had persistent metabolic academia.Additionally, the patient required pressors for blood pressure support.There was no documented relationship between the hero graft and the patient's death.The ifu provides the following instructions: "implantation of the hero graft is contradicted 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," and "remove 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.All bridging catheters should be cultured upon explant.In the event catheter tip cultures are positive, treat the patient with appropriate antibiotics to decrease the risk of the hero graft becoming infected." the ifu provides the following instructions regarding occlusion: "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an id [internal diameter] of at least 3mm to provide adequate arterial inflow to support the graft," and "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication." the ifu lists the following potential complications with the use of the hero graft: infection, sepsis, partial stenosis or full occlusion of prosthesis or vasculature, death.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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