MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; LOW ENERGY DIRECT CURRENT ABLATION SYSTEM

Model Number 20300101

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

Patient Problems Hemorrhage/Bleeding (1888); Embolism/Embolus (4438)

Event Date 11/10/2023

Event Type  Death  

Manufacturer Narrative

The nanoknife generator is not available to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A territory manager reported a patient death two days after an ire procedure using a nanoknife system (nanoknife 3.0 unitand six 25cm nanoknife probes).The procedure was a central liver tumor ablation with the initial plan to use (b)(4) units of 15cm probes, with a lateral intercostal approach.The doctor decided to change the approach to a central approach, which was more risky (hepatic artery and bile duct on the route) but allowing better framing of the lesion ((b)(4) probes of 25cm).Once the planning has been carried out on the epione machine, insertion of the (b)(6) nanoknife probes was performed at once without verification by the radiologist.Per the control scan: the needles are not in the right place.There was modification of the placement of the nk probes with an ultrasound unit control one by one to suit the ire procedure (distance and parallelism).Placement validation by control ct-scan.They then carried out the treatment: (b)(4) pulses (20+80) on each pair.2cm exposure: treatment without difficulty.Removal of the needles then control ct-scan.At that time, there was significant hemorrhage observed in the central area of the liver, a few cm from the treatment area (5-6cm from the treatment area).Emergency transfer of the patient to another operating room for radioembolization of the affected arteries: pancreatic and hepatic arteries.It was later reported on november 10, 2023, that the patient was stable.On november 12th, it was reported the patient died during the weekend after a second radioembolization.The physician doesn't think that the ire procedure is responsible.Additional information from provider: "we were able to fix the bleeding by taking it a second time but his liver did not support the treatment + embolization unfortunately.Unfortunately, these are the risks of such extreme gestures.This could have been a great success considering the total removal of the tumor.It is not related to the ire itself, but to the fact that it is reserved for cases normally considered impossible and without alternative.I'm going to review the schedule, my initial idea of lateral access would have been "safer" but would have left cancer".

Manufacturer Narrative

The nanoknife generator was not returned for evaluation/service since there was no report of unit malfunction during the procedure.In addition, there was no complaint allegation against probes used.Event is related to patient serious adverse event of vessel perforation, which is an anticipated procedural complication.The customer's reported complaint description of patient serious adverse event (i.E.Vessel perforation that resulted in hemorrhage) cannot be confirmed given the patient centric nature of this event.The nanoknife generator (and probe devices) were not returned for investigation evaluation since there was no reported complaint of nanoknife system malfunction during the procedure.The reported serious adverse event (sae) is listed in the device directions for use as potential adverse effects that may be associated with the use of the nanoknife system, i.E.Perforation/damage to critical anatomical structure and hemorrhage.In addition, physician stated the vessel perforation/hemorrhage is not linked to the ire procedure itself, but rather to the fact that it is reserved for the cases considered normally as impossible and without alternative.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 failure mode of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use which is supplied to the end user for the nanoknife system, states: nanoknife probe dfu 16910473-01: warnings: do not use a device with damaged insulation.Do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device.Attachments may damage the insulation and contribute to patient injury.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: arrhythmia, atrial, fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, reflex tachycardia, ventricular tachycardia, ventricular fibrillation, fistula formation, damage to critical anatomical structure (nerve, vessel, duct), hematoma, hemorrhage, hemothorax, infection, muscle contraction pneumothorax , reflex hypertension, unintended mechanical perforation, vagal stimulation, asystole and venous thrombosis.Nanoknife user manual, 16795933-21: electrodes that are not parallel to each other may result in an incomplete ablation.Inappropriately positioned electrodes or metal implants in the field may distort the desired ablation field.Avoid unnecessarily high voltage or excessive number of pulses.Avoid short-circuiting the electrodes when delivering pulses.Electrode to electrode contact or electrode to electrode spacing less than 5 mm (millimeters) may result in short circuiting during energy delivery resulting in incomplete ablation.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to the following: arrhythmia, pneumothorax, muscle contraction, hemorrhage, unintended mechanical perforation, infection, bradycardia, vagal stimulation, asystole, damage to critical anatomical structure (nerve, vessel, and/or duct)." a review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Reference: (b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18256647
• MDR Text Key: 329608334
• Report Number: 1319211-2023-00083
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Sex: Male