|
According to the notification form, "patient had hero graft for approximately 1.5 years.Recently had a number of clotting issues, so the decision was made to revise the hero graft and put in a new one.When removing the "old" hero graft to place a temporary catheter (until the hero graft case could be scheduled in the or.), she noticed the kink in the outflow component.She cut the outflow, placed it in a container to have me return to cryolife.A temporary catheter was inserted.".
|
|
The operative notes included a lot number of 0001661.According to the operative notes the patient is a (b)(6) female with end-stage renal disease.A hero graft was implanted on (b)(6) 2013 using the subclavian vein.The patient experienced multiple clotting complications the first of which occurred on (b)(6) 2013.For the clotting complications an array of interventions were performed including but not limited to multiple fistulograms, angioplasties and mechanical thrombectomies.For details on the complications and the interventions performed see the operative notes under medical records.The graft was also stented three times due to concerns over the grafts appearance, one of which the surgeon described as looking diseased.The patient had her venous outflow component (voc removed on (b)(6) 2015 due to the multiple clotting issues.During the explant extensive thrombus was noted in the voc.The graft was ligated.The patient had a second hero graft implanted on (b)(6) 2015 which was revised to use a gore acuseal graft in conjunction with the graft portion of the graft.The hero voc was returned dry within a small specimen cup.Crushing of the voc was noted at the approximate area where it likely encountered the clavicle.The wires of the voc were broken and frayed at the area of compression.It could not be determined if this area of breakage penetrated through the luminal wall.On this area of the compressed voc, evidence of light brown tissue-like material was noted on the external surface.Residual clot formation was noted within the lumen of the proximal end (the end connected to the agc - arterial graft component) of the voc, but was not evident in the distal end.The root cause for the compression and damage of the voc is consistent with contact at the clavicular junction.The resultant compression would cause occlusion and foster thrombus formation.The manufacturing record for lot 0001661 was reviewed by quality assurance/quality control (qa/qc), and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.This patient had a hero graft implanted in (b)(6) 2013.In (b)(6) 2013 the patient had her first of 10 interventions to restore graft flow secondary to graft clotting.The patient has a history of failed arteriovenous fistula (avf), which was noted to be aneurysmal and a source of pain and swelling; central vein obstruction was also documented prior to hero implant.The patient's medical history includes multiple comorbidities, including diabetes mellitus, hypocholesteremia, and hypertension.From the time of implant to the time of hero ligation, the patient underwent multiple fistulograms, angioplasties, mechanical thrombectomies, and stent placements to restore vascular flow.Thrombosis is the most common cause of vascular access dysfunction and a potential complication listed in the hero graft ifu.Residual clot formation was noted in the voc upon sample review.An increased risk for graft thrombosis could be caused by a hypercoagulability state or impaired blood flow through the graft.There was a history of "a number of clotting issues" in this patient.Precautions regarding inadequate anticoagulation are provided in the ifu.Alternatively, the crush/damage to the voc may have impaired blood flow, leading to graft thrombosis.As stated in the hero graft ifu, mechanical/rotational thrombectomy devices should not be used in the voc as internal damage may occur to these components.The surgeon completed multiple mechanical thrombectomies on the hero graft and the physical effect on the components cannot be verified without review of the entire sample.It is also unknown whether the patient was compliant with her dialysis schedule.As stated in the ifu, missed hemodialysis sessions significantly increase the number of thrombosis episodes in avfs and arteriovenous grafts (avg) it is not possible to determine the relationship between the hero graft and the clotting issues give the complex clinical history and limited sample review.During explant of the original hero graft the surgeon noted a kink in the outflow component.Device kinking or compression is listed in the hero graft ifu as a potential complication.The ifu identifies implant instructions and cautions to minimize the risk of device kinking.Those include use of a shorter introducer, specific note on advancing the voc, and caution on bending the voc beyond 2.5cm diameter.According to the operative notes provided for the procedure the surgeon originally "attempted the longer device, however, due to kinking, we converted this to the shorter sheath." the surgeon also chose to implant the graft through the subclavian vein, as opposed to the internal jugular (ij).As stated in the ifu, central venous access through any other veins, for example, the subclavian has not been studied and may increase the risk of adverse vents not encountered in the clinical trial.When using the subclavian vein for venous access, a more lateral percutaneous approach might mitigate the risk of clavicle crush or occlusion of the venous outflow component (voc).Consideration should be made to follow these patients with clavicle imaging to monitor the potential of interaction of the clavicle and first rib with the voc.Evidence from the sample review suggested the following: crushing of the voc was not at the approximate area where it likely encountered the clavicle and first rib.During intervention procedures performed in early (b)(6) 2014 the surgeon noted that "a portion in the mid graft section, which appeared to diseased and accounting for the reason that the graft clotted in the first instance." the surgeon went on to say that this section was a "significant cosmetic defect;" this observation was not confirmed on sample review as the arterial graft component (agc) was not returned.The surgeon chose to stent the region with a 7x10 viabahn graft on this occasion and re-stented the same area in (b)(6) 2014 and then again in (b)(6) 2015 before explanting the hero graft in (b)(6) 2015.At this time, it is not known that the surgeon specifically meant by "diseased graft." at the point of observation, the patient had already undergone 4 previous interventions for clotting and the graft was over one year old.It is unclear if the interventions had caused damage to the agc.The patient also reported "soreness in extremity" in her follow-up post hero explant/implant in mid-(b)(6) 2015.The hero ifu lists pain as a potential vascular graft and catheter complication.The surgeon later notes that the surgical wounds "are healing well," with no indication of abnormal healing.From the information provided it appears that the pain is related to surgery as anticipated in the ifu.The root cause for the reported events is unknown; however, all complications noted in the complaint are known potential complications of the hero graft.The ifu lists the following potential complications with the use of the hero graft: vascular graft revision/replacement, partial stenosis or full occlusion of prosthesis or vasculature, device kinking or compression, and site pain.The sample review also noted damage to the voc consistent with damage caused by crushing between the clavicle and first rib.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.
|
|
According to the notification form, "patient had hero graft for approximately 1.5 years.Recently had a number of clotting issues, so the decision was made to revise the hero graft and put in a new one.When removing the "old" hero graft to place a temporary catheter (until the hero graft case could be scheduled in the or.), she noticed the kink in the outflow component.She cut the outflow, placed it in a container to have me return to cryolife.A temporary catheter was inserted.".
|
