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At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.Follow up with user the firm has been in communication with the user to request followup information, to supplement this investigation.At the time of this mdr report, some responses are still pending.The patient was reported to be a 65-year old male with multiple myeloma.The firm is awaiting additional information regarding the patient's pre-existing medical condition.The procedure was described as a treatment for a pathologic impending fracture of the left humerus.The first attempt to place 2 simultaneous illuminoss balloons resulted in the puncture and leak of one of the balloons, and both balloons were removed.The canal was irrigated and flushed.The second attempt to place a single balloon resulted in the puncture and leak of that balloon, and it was removed.The canal was re-irrigated and aspirated.In the third attempt to stabilize the fracture, an illuminoss balloon was placed, infused with monomer, and the curing process for the illuminoss implant was initiated.After the curing process was begun, the patient experienced heightened blood pressure and oxygen issues, and required resuscitation in the or.The patient was moved to the icu.The patient passed later that evening in the icu.At the time the firm received the initial report, and verified in followup communications, the user/facility had not identified a cause of the patient's death.The firm requested and is awaiting intra-operative x-rays from the case.X-rays: radiographs of the treated anatomy were requested from the user, and are anticipated but not yet received.Returned product evaluation: device evaluation in this case is not possible as it is believed that the device remains implanted, although this information is still being verified by the firm.Dhr review: a review of manufacturing records for the product involved in this complaint was performed, and found that the product met specifications at the time of manufacture and release.Medical oversight review: the firm performed an initial internal medical oversight review of the case, in which the information known about the case was reviewed.Illuminoss clinical and medical affairs met with independent medical oversight and identified additional information to request from the user to support the investigation.These requests were made to the user, for x-rays and operative reports from the procedure, and any additional information the user or their institution may have about the possible cause of death.The internal medical oversight review of this case in on-going at the time of this report.
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At the time of this followup mdr report, the firm's investigation into this event has been completed.This follow up mdr is to submit new information.The firm received additional communications from the treating physician including the final results of the autopsy, and performed additional internal medical oversight review as well as a supplemental literature review to complete the complaint investigation.Follow up with user: the firm has been in communication with the user to request followup information.The patient was a 65-year old male with multiple myeloma.The firm received additional details of the patient pre-existing comorbidities: primary t-cell therapy, radiation prior to surgery but not in immediate proximity to the lesion being treated, and an osteolytic lesion.The firm received intra-operative x-rays from the case on 09jan2024.· the firm was notified on 15nov2023 that there would be an autopsy performed, and received preliminary results of that autopsy on 05dec2023.Initial results indicated nothing notable in the pathology, and nothing obvious in the lung pathology.· followup with the user on 21dec2023 provided additional information.During the procedure, the patient became hypoxic and hypotensive.The bronchoscopy and x-ray both showed pulmonary edema.The patient was revived and was being monitored heavily.They were trying to get him on an ecmo device but he died while they were transferring him to the icu.The user did not identify a definitive cause of the patient death.He posited that there could have been a fat embolism released from the im canal, or ards, or cardiovascular collapse.Ultimately he couldn't determine.· the treating institution performed an additional specialist lung pathologist review of the autopsy.Results received by the firm on 02jan2024: no findings in the report of anything related to or causative that was attributed to the illuminoss product (i.E.No monomer found in the lungs.).The treating institution concluded that most likely pulmonary edema contributed to the patient adverse event.· the user and the treating institution were able to identify that pulmonary edema likely contributed to the patient's death, but were unable to determine the cause of the pulmonary edema to the firm's knowledge.The role of the illuminoss implants, and leaked monomer, in contributing to the patient death was investigated, and no evidence found that the device caused or contributed to the patient death.Cause of balloon leak: the treating physician identified that the cause of the balloon leaks experienced in this case was from contact between the balloon and the sharp edge of the bone defect in the anatomy being treated, which punctured the balloon while being infused with monomer.Cause of patient death: the definitive cause of death in this case was not able to be determined.Followup medical oversight reviews were conducted as more information was received from the user about this case.Other role that leaked monomer might have played in this case was investigated.The hospital didn't find anything notable in the pathology from the autopsy performed, and nothing obvious in the lung pathology.The hospital's lung pathologist review of the autopsy and case concluded with no findings of monomer in the lungs, no findings of illuminoss material anywhere in their review, and that there was nothing found of interest nor causative that was attributable to the illuminoss product.O 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 a 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.Sick patients may also experience a primary cardiac event related to the stress of the injury being treated, anesthesia and surgical manipulation of an injured extremity, contributed to by other pre-existing medical conditions.The user reported that this patient was receiving primary t-cell therapy, had radiation prior to surgery, and was being treated for an osteolytic lesion.The user reported that at the time of the index complication, "bronchoscopy and x-rays both showed pulmonary edema".O with the information available to illuminoss, internal medical oversight therefore concluded: the autopsy reports do not appear to show any causal relationship between leaked monomer and pulmonary complications.Of the other known possible causes of patient death during this kind of procedure, based on the information provided, medical oversight concluded that the pulmonary edema most likely led to a cardiac event in this very ill 65 year old male, which led to patient death.A literature review was performed 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, the bone in which the fracture is experienced, and the trauma of having a fracture.Specifically, patients experiencing fracture of the long bones and pelvis (femur, humerus, tibia, pelvis) are significantly more at risk than similar patients with fractures in other bones.A surgical procedure of any kind increases the risk.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 this patient population.This literature review confirmed that there is a risk of fat embolism for this patient population from an im fixation procedure.This literature review confirmed that myocardial infarction due to patient co-morbidities is also a risk for this patient population.This literature review also confirmed that the absence of radiation therapy approached significance with respect to decreased overall vte risk, therefore having had radiation put this patient at a higher risk for vte.Review of ifu :the firm identified no deviations from the manufacturer's instructions for use in this case.The procedure performed was for an on-label indication (humerus of a skeletally mature adult).The surgical technique guide includes instructions for removal of leaked monomer in the event that monomer leak is experienced, and the user followed these instructions.There is no evidence that mis-use or user error contributed to this event.The ifu explains the following risks: · that "as with any im fixation system, the following can occur: thromboembolic event or fat embolism (blood clot, fat, or other material that could result in organ damage or failure)".· that "risks specific to a photodynamic curing system can include: balloon leakage".Conclusion: the most likely cause of the balloon leaks experienced in this case was as reported from the user, from contact between the balloon and the sharp edge of the bone defect in the anatomy being treated as the implants were being infused with monomer.The cause of the patient death in this case remains unknown, although the evidence allowed leaked monomer to be ruled out as the cause of death.Based on the autopsy results, nothing causative attributable to the illuminoss product was identified, and the lung pathologist review specifically concluded no illuminoss material (e.G.Monomer) was found in the lungs.Based on the results of testing at the time of the index complication, the results of the autopsy performed, internal medical oversight review, and the literature review performed, the most likely cause of the patient death was cardiac event due to patient pre-existing medical conditions complicated by pulmonary edema.The cause of the pulmonary edema remains unknown, and this probable cause of death can not be fully verified with the information available.Without a conclusion from the treating physician about a known cause of death, the following other possible causes could not be ruled out: a fat embolism released by the fracture or the device implantation into the intramedullary canal; an embolism caused by a blood clot; the patient's pre-existing co-morbidities; or a primary cardiac event related to the stress of the procedure.Of these, the risks that may be device-use related are explained in the device labeling and risk documentation.Specifically, "thromboembolic event or fat embolism (blood clot, fat, or other material that could result in organ damage or failure)." there is no indication that this event was the result of a malfunction, failure or change in the characteristics or performance of the device, or device misuse.
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