MAUDE Adverse Event Report: EXIMO MEDICAL LTD. AURYON LASER SYSTEM 100-120 VAC

Model Number EXM-2001-1100

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

Patient Problems Chest Pain (1776); Vomiting (2144); Diminished Pulse Pressure (2606)

Event Date 06/28/2021

Event Type  Death  

Manufacturer Narrative

The auryon unit (serial number (b)(4)) is not returning to the manufacturer for evaluation at this time as there was no allegation of malfunction during this event.The investigation for this adverse event is in process.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics' clinical specialist reported that during an atherectomy procedure, while utilizing a 100-120 vac eximo atherectomy laser system at an end user facility, the patient complained of chest pain and it was observed that the patient's blood pressure appeared to be low.At that time, the physician stopped the procedure to assess the patient.During assessment, the patient vomited, coded, and ultimately expired.The end user physician and clinical specialist reported that there was no allegation of product deficiency or malfunction on or against the machine or any angiodynamics' device(s).Additional information regarding the patient and the event, including medical records and the death certificate were requested, but not provided by the end user.The laser system is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

The auryon unit (serial number (b)(6)) is not returning to the manufacturer for evaluation at this time as there was no allegation of malfunction during this event.The investigation for this adverse event is in process.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

Additional event information obtained reported: an angiodynamics' clinical specialist reported an event occurring during an atherectomy procedure.At the start of the procedure, the patient with rutherford 5 right lower extremity critical limb ischemia was placed on the special procedures table, prepped and draped as per normal procedure.The patient was given 1mg of versed and 50mcg of fentanyl intravenously.Under ultrasound guidance, access to the left common femoral artery allowed placement of.018 wire.The procedure was carried out with angiography confirming location and type of the lesions.At this point it was determined to perform laser atherectomy using the 1.5 auryon laser device.This laser was placed over the wire without issue, and followed the up and over sheath to the flow divider where it traversed the flow divider and down to the distal right iliac stent.Athetrectomy was then performed in the external iliac.After this, the laser was placed at the distal anastomosis where it was again activated.It was not activated throughout the course of the hemodynamically significant disease with bypass graft.The laser was then placed further distally and atherectomy was performed using the prescribed method of 1mm/s in the native popliteal artery.At this point the patient's heart rate was 70-80 in sinus rhythm, oxygen saturation 98-100%.Blood pressure was 120-130 systolic.During lasing of the popliteal the patient reported itching behind his knee and a metallic taste, he then immediately reported burning, tingling sensation in the chest, both arms, neck & face.Rn increased his fluids and gave a vial of solu-medrol intravenously with in a 30 second span.During this time the patient's heart rate and pressure dropped.The patient described a need to vomit, turned his head to the left to do so, at which time he coded.Immediate code blue was called including 911.Immediate cpr was commenced along with an ambubag.It was noted the patient was not being oxygenated despite the ambubag being appropriately placed on the patient's nose and mouth.The patient was intubated with an endotracheal tube and with a stethoscope, good oxygenation was able to be heard in both lungs.Full resuscitation was then proceeded according to approved guidelines in conjunction with the paramedics who hqad arrived.Despite best efforts along with communication with the emergency room physician at desert springs hospital the patient was unable to be resuscitated.The patient was was pronounced deceased.Used during the procedure was a 5f precision sheath for access and then exchanged for a 6f precision sheath, and a 0.14 viper wire.The targeted lesion was located in the external iliac artery between the distal stent and the takeoff of a bypass graft.The energy used was 50mj/mm and 60mj/mm, advancing at 1mm per second.The total treatment time was 6 minutes and 50 seconds.There was no blood aspiration issues and there was no difficulty advancing over the wire.No laser alarms were received and no hardware/mechanical/visual issues were noted.There is no allegation of any device malfunction or issue associated with the event.

Manufacturer Narrative

The auryon unit (serial number: (b)(6) was not returned to the manufacturer for evaluation as the unit functioned as intended during the procedure.The patient expiration was determined to be unrelated to the atherectomy procedure, i.E.Co-morbidity cardiac issues.The customer's reported complaint of patient death during atherectomy procedure could not be confirmed given the nature of the serious adverse event.There was no reported auryon catheter or laser system malfunction during the procedure.The patient expiration was determined to be unrelated to the atherectomy procedure, i.E.Co-morbidity cardiac issues.A review of the device history records (service order history) was performed for the reported serial number: (b)(6) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all component, assembly, and performance specification prior to distribution; i.E.No ncr associated with reported failure mode.Labeling review: the user manual, which is supplied to the user with this unit states: safety precautions: in any event of an internal fault in the laser system, turn off the laser system and call an eximo medical technician for further instructions.Disposable device review: this angiodynamics hardware unit has a related disposable device, however, the disposable device could not affect the reported serious adverse event (cardiac issues).Dhr review of ship history lots confirmed that the lots met all material, assembly and performance specifications, e.G.No manufacturing non-conformance reports were issued.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference: (b)(4).

• Brand Name: AURYON LASER SYSTEM 100-120 VAC
• Type of Device: AURYON LASER SYSTEM 100-120 VAC
• Manufacturer (Section D): EXIMO MEDICAL LTD.; 3 pekeris street; glens falls, ny 12801, rehovot 76702 03; IS 7670203
• MDR Report Key: 12176921
• MDR Text Key: 261809854
• Report Number: 1319211-2021-10015
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K181642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EXM-2001-1100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 91