MAUDE Adverse Event Report: ILLUMINOSS MEDICAL, INC PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN VIVO INTRAMEDULLARY FIXATION ROD

Catalog Number USSL-2213220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 07/26/2023

Event Type  Death  

Manufacturer Narrative

Returned product evaluation: the device remained implanted and was not returned for evaluation.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.A review of complaint data found that there were no other complaints for this lot number.Follow-up information from the user: in a follow up call with this user, he described his plan for the treatment, the additional instrumentation to be used, the patient pre-existing medical conditions, and the steps performed during this case.There was no reported deviation from the manufacturer's instructions, and the user reported that the procedure had been progressing as expected, and that no product problems were observed.This was an elderly patient (78) with some co-morbidities, who presented with an acute medial femoral condylar fracture that was unstable.The patient's pre-existing medical conditions included diabetes, chronic respiratory disease, chronic pain syndrome, scoliosis, radiculopathy, hypothyroidism, atrophy, non-ambulatory - wheel chair bound, osteopenia, depression, anxiety, malnourished, cognitive decline, vit.D deficient, and taking a beta-blocker for cardiac issues.The user's plan was to treat the fracture minimally-invasively, to do a medial approach through a stab incision, place an illuminoss implant [size 22/13 x 200] across the fracture, and put in some screws through the illuminoss implant.The procedure to place and infuse the illuminoss implant was completed without issues.About 5 minutes into the curing process, the patient's heart rate dropped and they increased the bp by using pressors to bring it back up.The patient's blood oxygen dropped to 46% and came back up into the 90s% within 5 minutes and stayed that way for the rest of the procedure.The user had been planning on putting in some screws but did not do anything further and closed the surgery site.The patient was sent to the icu and the blood oxygen was 96%.The patient expired 1.5 hours later in the icu.The user concluded that neither he nor his institution identified the cause of the patient death.The patient had a dnr order so they did not attempt to revive the patient after decline in the icu.He shared that his impression was that it could be fat embolism syndrome.Thromboembolic events and fat embolisms that could result in organ damage or failure are known risks of im fixation procedures, which are included in the product labeling.The firm requested anesthesia pre-op assessment and operative anesthesia records for this case.The user provided information from these records to the firm via phone call.Medical oversight review: illuminoss hosted an internal medical oversight review for this case , in which the firm reviewed the case details and x-rays provided by the user.The user concluded that they did not identify a cause of death, but shared the opinion that it could have been fat embolism syndrome.The firm's medical oversight review considered the case and observed that the fracture was nicely reduced, and no apparent device deficiencies or user deviations from instructions were present.Medical oversight identified that the possible causes were 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 not related to the fixation procedure, 3) the patient's pre-existing co-morbidities or 4) a primary cardiac event related to the stress of the trauma, anesthesia and surgical manipulation of an injured extremity.Medical oversight observed that the patient's oxygenation came back and normalized after the initial decline during the procedure.Based on this progression, and without any additional information or opinions from the anesthesiologists, medical oversight concluded that the most likely cause of death in this case was primary cardiac event.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 comorbidities, 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 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.This literature review also confirmed that myocardial infarction due to patient co-morbidities is also a risk for this patient population.Review of ifu: a review of us implant ifu 900356 rev.W was performed.There is no indication that the user deviated from the manufacturer's instructions for intended use of the product.The ifu contains the risk 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)".Conclusion: based on this information, medical oversight review, and the literature review performed, the most probable cause of this patient's death was identified as a primary cardiac event related to the stress of the trauma, anesthesia, and surgical manipulation of an injured extremity for an elderly patient with pre-existing medical conditions.Without an autopsy or further medical records, the following possible causes could not be ruled out: a fat embolism released by the fracture or the device implantation into the intramedullary canal, a thromboembolic event caused by a pre-existing medical condition not related to the fixation procedure, and the patient's pre-existing co-morbidities.Of these possible causes, 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 a result of malfunction, failure, change in the characteristics or performance of the device, or device misuse.

Event Description

During a procedure to treat a 78-year old female for a traumatic distal femur fracture with an illuminoss implant, the patient declined while curing of the balloon in surgery.The patient passed in icu 1.5 hours later.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 17574028
• MDR Text Key: 321447262
• Report Number: 3006845464-2023-00040
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL22132200
• UDI-Public: M986USSL22132200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: USSL-2213220
• Device Lot Number: 420947
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female