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

Model Number USSL-1700280

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.The firm has conducted a review of the manufacturing records for the device in this case, and found that the device met specifications at the time of manufacture and release.Device evaluation in this case is not possible as the device remains implanted.The firm has conducted a follow-up interview with the treating physician, and collected additional information about the implantation procedure, his observations about the patient condition at the time of the procedure, and his specific observations about the patient distress experienced.The treating physician described that the surgery was originally scheduled for monday the week before, but the patient coded and taken to the icu for acute renal failure, and was not cleared for surgery until wednesday.Due to the patient's multiple comorbidities and frailty, the treating physician decided to do a less invasive surgery to treat the fracture (illuminoss implant).The implantation procedure progressed without any device-related issues observed.The treating physician noted her hemoglobin started at 7-8 (well below normal) and she had severe intraoperative blood loss.After the monomer was infused into the balloon and the implant curing process was started, the patient became extremely hypotensive, hypoxic, and coded.Her systolic pressure was 180 at one point.The patient was stabilized using chemical cpr, chest compressions, and blood infusion.The patient never lost a pulse.The patient was stabilized within 5 minutes.At this point the illuminoss implant was still in the process of curing.The treating physician determined to complete the procedure.The procedure progressed and was completed.As of (b)(6) the patient was out of the icu and returned to the floor, and her condition was stable.The treating physician agreed to share with the firm records from the case including x-rays, anesthesia records, and a specific list of the patient co-morbidities.Due to travel and availability of the treating physician, the firm has not yet received these records.The firm performed an internal medical oversight meeting for this case, with the known information.With the additional information that will be provided in the medical records for this case, the firm will complete the complaint investigation.A follow up mdr will be submitted when further information is known about this case.

Event Description

On (b)(6) 2022, an 82 year old female patient with dementia and multiple co-morbidities was treated for a traumatic distal femur fracture with an illuminoss implant [size ussl-1700280].After the monomer was infused into the balloon and the implant curing process was started, the patient became extremely hypotensive, hypoxic, and coded.The patient was stabilized using chemical cpr, chest compressions, and blood infusion.The procedure progressed and was completed.As of (b)(6) the patient outcome was good.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including - the investigation findings codes - investigation conclusion codes - and this manufacturer's narrative with the firm's root cause conclusions.The firm has conducted a review of the manufacturing records for the device in this case, and found that the device met specifications at the time of manufacture and release.Device evaluation in this case is not possible as the device remains implanted.The firm has conducted a follow-up interview with the treating physician, and collected additional information about the implantation procedure, his observations about the patient condition at the time of the procedure, and his specific observations about the patient distress experienced.The treating physician described that the surgery was originally scheduled for monday the week before, but the patient coded and taken to the icu for acute renal failure, and was not cleared for surgery until wednesday.Due to the patient's multiple comorbidities and frailty, the treating physician decided to do a less invasive surgery to treat the fracture (illuminoss implant).The implantation procedure progressed without any device-related issues observed.The treating physician noted her hemoglobin started at 7-8 (well below normal) and she had severe intraoperative blood loss.After the monomer was infused into the balloon and the implant curing process was started, the patient became extremely hypotensive, hypoxic, and coded.Her systolic pressure was 180 at one point.The patient was stabilized using chemical cpr, chest compressions, and blood infusion.The patient never lost a pulse.The patient was stabilized within 5 minutes.At this point the illuminoss implant was still in the process of curing.The treating physician determined to complete the procedure.The procedure progressed and was completed.As of november 11th, the patient was out of the icu and returned to the floor, and her condition was stable.Treating physician's analysis of cause: the user thinks it was probably a combination of everything (comorbidities, blood loss, balloon expansion into the canal) which caused the patient to code.The timing of the patient experiencing distress right after balloon expansion prompted the user to consider if the expansion of the balloon may have played a role, although he stated it is also very possible that she coded because she almost bled out.The firm performed an internal medical oversight review for this case, with the known information.Medical oversight observed that when the patient became hypotensive and crashed it was likely due to blood loss and bottoming out.Medical oversight noted there is no record of respiratory oxygenating problems, that would be indicative of micro emboli to the lungs caused by pressurization of the femur.This could be the case of an older patient with acute blood loss experiencing a hypotensive episode.Medical oversight noted the patient's overall frailty, as demonstrated by experiencing similar distress (coding) a few days prior to this event.Medical oversight concluded by agreeing with the user's statement that the patient coding could have been due to a combination of everything (co-morbidities, blood loss, the trauma of a femur fracture, undergoing surgery, expansion of the balloon in the canal).The timing that she coded soon after the balloon infusion and expansion may not be indicative of a causal chain of events.Medical oversight also concluded by agreeing with the user's statement that the patient distress could have been solely due to the patient's blood loss during the procedure.The medical oversight review concluded that additional review would be beneficial if the user could provide the medical records the firm has requested.Although the treating physician agreed to share with the firm records from the case including anesthesia records, the firm has not yet received these records.Conclusion the cause of the event could not be definitely determined.The most probable causes of the patient's adverse event are 1) acute blood loss leading to a hypotensive episode, or 2) a combination of distress factors on the patient including co-morbidities, severe blood loss, the trauma of a femur fracture, undergoing surgery, and expansion of the balloon in the canal.Although it cannot be ruled out, medical oversight review determined it was unlikely that micro-emboli released by the expansion of the balloon within the canal was the cause of the patient adverse event, as there is no record of respiratory oxygenation issues.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.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY 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: 15942255
• MDR Text Key: 305087150
• Report Number: 3006845464-2022-00023
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL17002800
• UDI-Public: M986USSL17002800
• 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,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: USSL-1700280
• Device Catalogue Number: USSL-1700280
• Device Lot Number: 410418
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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): Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian