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A review of manufacturing records for the product involved in this complaint was performed, and found the product met specifications at the time of manufacture and release.As the description of the complaint stated the balloon ruptured while inflating, special attention was paid to the manufacturing steps involving leak testing and balloon burst strength.All assemblies in this lot passed the leak test and vacuum pressure test, and the balloon raw components used in this lot met the minimum burst specification.The implant was not returned for evaluation.Follow-up interviews with the illuminoss rep were performed regarding the procedure.The rep reported the steps performed by the treating physician to prepare the bone canal, prepare the implant, place the implant, and infuse the implant.From these interviews, it was confirmed that the implant preparation step to evacuate all of the air out of the implant was followed, and that the implant during this preparation step did successfully hold a vacuum.This, in addition to the review of manufacturing records that demonstrate the device met specifications at the time of manufacture and release, allow the investigation to eliminate a manufacturing defect in the balloon as a potential cause of the balloon leak.In a follow-up interview with the treating physician, the user provided details about of the implantation procedure, and the patient's pre-existing medical conditions.The user described the steps of the distal femur fracture illuminoss single balloon and plate procedure he followed.He used one illuminoss implant in the distal femur.He described his approach as starting with a starter awl, then inserting the sheath and dilator, to then advance the balloon into the canal.He confirmed that he did not ream or take other steps to clear out the canal prior to inserting the balloon, which is a deviation from the manufacturer's instructions to clear the canal from the entry hole across the fracture to prepare a pathway for the implant.He described identifying that the balloon had been damaged intraoperatively by sight and feel, seeing that the balloon first had crisp lines as he was infusing it with monomer, then he felt the pressure change (lessen), and then the lines became blurry.This description matches a scenario where the soft-sided pet balloon made contact with a sharp object such as a clamp, bone fragment, or other hardware that was present in the canal space.The user verified that there was no other hardware present within the canal space at the time of balloon insertion or inflation.Given the review of manufacturing records, and the interview information collected from the company rep and the treating physician, the most likely cause for the balloon leak was intraoperative balloon damage from contact between the balloon and a sharp bone fragment as it expanded while being infused with monomer.The balloon was able to draw a vacuum during implant prep, which indicates that it did not have a leak at that point in the procedure.The user's description of the look and feel of the implant during initial monomer infusion support the analysis that the device did not have damage at the beginning of the balloon infusion process.His description of the change in pressure that he felt, and then subsequent change in look of the balloon support an analysis that the balloon experienced damage in situ, within the canal during the infusion process.The user reported that there was no hardware within the canal at the time of monomer infusion.In light of these facts, the balloon damage experienced was most likely the result of contact with a sharp bone fragment as the balloon was expanded within the canal upon monomer infusion.The risk of balloon leakage is included in the product labeling.The cause of the patient cardiac event and death in this case remains unknown.The treating physician reported that the patient experienced a "cardiac event" after he had removed the damaged balloon.The procedure at that point was halted, and resuscitation was attempted.The patient was not able to be resuscitated.The user reported that there was no autopsy performed, and the cause of the patient's cardiac event was not known.He reported that the patient's pre-existing medical conditions included copd and dementia.Illuminoss requested the anesthesia pre-op evaluation and the operative anesthesia record for this case, but the treating physician was not able to provide them.The complaint investigation team paid particular attention to the role that the intraoperative balloon damage and monomer leak experienced during this procedure could have played in the patient's cardiac event.Timing: the potential harm of this risk (balloon leak) per the device risk documentation is extended surgical and anesthesia time, and the increased risk to a patient as a result.As the physician had not yet cured the implant nor performed the planned plating of the fracture when the patient decline began, prolongation of the planned procedure due to intraoperative balloon damage was not the cause of the patient death.The planned procedure would have required a much longer duration.Presence of monomer outside the balloon, within the bone canal: the manufacturer has performed biological safety testing of the uncured monomer, including animal studies, as part of the original device design validation.One device validation study included in vivo animal testing that included the injection of uncured monomer directly into the canals of test subjects at doses equivalent to the potential human dose in the event of a balloon rupture during device deployment.This resulted in no subject fatalities at any dose level of the illuminoss photodynamic monomer, nor were any overt signs of severe toxicity observed.A literature search performed for this complaint investigation also identified a pre-clinical publication that included in vivo animal testing done in rabbits and followed them out to 1 year.In this series, liquid monomer was injected directly into the intramedullary canals.None of these test subjects experienced perioperative mortality and no systemic changes were noted on any harvested organs.This testing supports the conclusion that it is highly unlikely that the presence of leaked monomer within the patient's bone canal was in any way causative of the cardiac event experienced.There are known risks to im fixation procedures that are included in the product labeling, including thromboembolic event from a blood clot, contributed to by the patient's pre-existing medical conditions, and fat embolism resulting from the fracture or the fixation procedure to treat it.Both of these risks can lead to organ failure, and in this case either of them may be possible causes of the cardiac event experienced.The cause of the cardiac event in this case may also be the patient's copd or other pre-existing medical conditions.A literature search was conducted to supplement this investigation into the potential causes of the patient death.This literature review confirmed that the risk of mortality for fracture patients is most significantly contributed to by patient age (<65), patient co-morbidities, and also the bone in which the fracture is experienced, and the traumatic nature of the fracture.Specifically, patients experiencing fracture of the long bones (femur, humerus, tibia) are more at risk than similar patients with fractures in other bones.The literature review supports an evaluation that the risk of mortality for elderly and sick long bone fracture patients is present due to the presence of the fracture itself.A surgical procedure of any kind increases the risk.This literature review found no definitive evidence to suggest that the deviation from the manufacturer's instructions to clear out the canal prior to implant insertion is a practice that can be correlated to the risk of patient mortality for fracture fixation procedures.This literature review confirmed that the risk of thromboembolic event due to patient co-morbidities, and pulmonary embolism from a clot is a risk for intramedullary fracture fixation procedures.This literature review confirmed that there is a risk of fat embolism - both from the presence of the fracture itself, as well as from an im fixation procedure.Conclusion: the cause of the patient's cardiac event and death in this case remains unknown.No autopsy was performed, and the treating physician and institution gave no conclusion as to the cause.The procedure performed was for an on-label indication (in the femur to provide supplemental fixation to an anatomically appropriate fda-cleared fracture fixation system).Although there was a deviation from the manufacturer's instructions for use to clear out the canal prior to inserting the illuminoss balloon, there is no indication that this was causative to the patient cardiac event, and there were no other deviations from the manufacturer's instructions for use.The manufacturer has confirmed that the product met specification at the time of manufacture, release, and preparation for this procedure, and identified the most likely cause of the balloon damage and leak was contact with a sharp bone fragment as the balloon was expanded within the canal upon monomer infusion.Device validation and pre-clinical studies include animal testing that demonstrates that it is highly unlikely that the presence of leaked monomer within the patient's bone canal was in any way causative of the cardiac event experienced.Based on this information and the literature review performed, the most probable causes of the patient's terminal event and death therefore remain 1) a fat embolism released by the fracture or the device implantation into the intramedullary canal, 2) a thromboembolic event caused by a pre-existing medical condition, or 3) a cardiac event related to the patient's pre-existing co-morbidities (copd, dementia), or the stress of the trauma, anesthesia and surgical manipulation of an injured extremity.
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