BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISUALASE SYSTEM

    MDR report key: 20126120 · Received September 3, 2024

    Report

    Report Number
    1723170-2024-02470
    Event Type
    Death
    Date Received
    September 3, 2024
    Date of Event
    June 6, 2021
    Report Date
    September 3, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDICAL ASSESSMENT WAS PERFORMED AND THEY FOUND THAT DUE TO THE AGGRESSIVE NATURE AND PRIOR SURGERY HISTORY, PATIENTS OFTEN HAVE A S URVIVAL RATE OF 1 YEAR EVEN PRIOR TO RECEIVING LITT PROCEDURE. THE MAIN GOAL WAS TO PROVIDE AN ADDITIONAL TREATMENT OPTION WHEN REVISION SURGERY WAS NOT AVAILABLE. MEDICAL SAFETY ASSESSES REPORTED DEATH OF 10 OUT OF 19 STUDY PARTICIPANTS WITHIN 2 YEARS POST LITT P ROCEDURE AND THE REPORTED SEVERITY IN THESE CASES AS INHERENT DISEASE PROGRESSION AND MEDICAL COMPLICATIONS ASSOCIATED WITH AGGRESSIVE PREVIOUSLY TREATED PRIMARY AND METASTATIC BRAIN TUMORS. ONE PATIENT EXPERIENCED INCREASED EDEMA SURROUNDING THE LASER ABLATION ZONE 2 DAYS POST PROCEDURE, AND ONE PATIENT EXPERIENCED HEMORRHAGE AS EVIDENCE ON MRI WITH DEATH OCCURRING WITHIN 30 DAYS POST PROCEDURE. MEDICAL SAFETY ASSESSES THE MORBIDITY OUTCOMES AND THEIR REPORTED SEVERITIES IN THESE CASES AS LABELED COMPLICATIONS. PER VISUALASE¿ MRI-GUIDED LASER ABLATION SYSTEM, WHICH STATES ¿POTENTIAL ADVERSE EVENTS ASSOCIATED WITH DAMAGE TO CRITICAL STRUCTURES MAY INCLUDE: INCREASED INTRACEREBRAL EDEMA OR PRESSURE. INTRACRANIAL BLEEDING¿. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    DABECCO, R., GIGLIOTTI, M.J., MAO, G., MYERS, D., XU, L., LEE, P., RANJAN, T., AZIZ, K., YU, A. LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR INTRACRANIAL LESIONS: A SINGLE-INSTITUTIONAL SERIES, OUTCOMES, AND REVIEW OF THE LITERATURE. BRITISH JOURNAL OF NEUROSURGERY. 2024. VOL. 38. NO. 3, 632¿638. HTTPS://DOI.ORG/10.1080/02688697.2021.1947972 INTRODUCTION: LASER INTERSTITIAL THERMAL THERAPY (LITT) IS A MINIMALLY INVASIVE TREATMENT METHOD IN MANAGING PRIMARY BRAIN NEOPLASMS, BRAIN METASTASES, RADIATION NECROSIS, AND EPILEPTOGENIC LESIONS, MANY OF WHICH ARE LOCATED IN OPERATIVE CORRIDORS THAT WOULD BE DIFFICULT TO ADDRESS. ALTHOUGH THE USE OF LASERS IS NOT A NEW CONCEPT IN NEUROSURGERY, ADVANCES IN TECHNOLOGY HAVE ENABLED SURGEONS TO PERFORM LASER TREATMENT WITH THE AID OF REAL-TIME MRI THERMOGRAPHY AS A GUIDE. IN THIS REPORT, WE PRESENT OUR INSTITUTIONAL SERIES AND OUTCOMES OF PATIENTS TREATED WITH LITT. METHODS: WE RETROSPECTIVELY EVALUATED 19 PATIENTS (AGE RANGE, 28¿77 YEARS) WHO UNDERWENT LITT AT ONE OR MORE TARGETS FROM 2015 TO 2019. PRIMARY ENDPOINT OBSERVED WAS MEAN PROGRESSION FREE SURVIVAL (PFS) AND OVERALL SURVIVAL (OS). RESULTS: SEVEN PATIENTS WITH GLIAL NEOPLASMS AND 12 PATIENTS WITH METASTATIC DISEASE WERE REVIEWED. AVERAGE HOSPITALIZATION WAS 2.4 DAYS. MEDIAN PFS WAS 7 AND 4 MONTHS IN THE METASTATIC GROUP AND PRIMARY GLIAL NEOPLASM GROUP, RESPECTIVELY (P ¼ 0.01). MEDIAN OS FROM TIME OF DIAGNOSIS WAS 41 AND 32 MONTHS (P ¼ 0.02) AND MEDIAN OS AFTER LITT THERAPY WAS 25 AND 24 MONTHS (P ¼ 0.02) FOR THE METASTATIC AND PRIMARY GLIAL NEOPLASM GROUPS, RESPECTIVELY. ONE PATIENT EXPERIENCED IMMEDIATE POST-PROCEDURAL MORBIDITY SECONDARY TO INCREASED INTRACEREBRAL EDEMA PERI-LESIONALLY WHILE ONE PATIENT EXPERIENCED POSTOPERATIVE MORTALITY AND EXPIRED SECONDARY TO HEMORRHAGE 1-MONTH POST-PROCEDURE. MEDIAN FOLLOW-UP WAS 10 MONTHS. CONCLUSION: LASER INTERSTITIAL THERMAL THERAPY (LITT) IS A SAFE, MINIMALLY INVASIVE TREATMENT METHOD THAT PROVIDES SURGEONS WITH CYT OREDUCTIVE TECHNIQUES TO TREAT NEUROSURGICAL CONDITIONS. BOTH PFS AND OS APPEAR TO BE MORE FAVORABLE AFTER LITT IN PATIENTS WITH METASTATIC DISEASE. IN PROPERLY SELECTED PATIENTS, THIS MODALITY OFFERS IMPROVED SURVIVAL OUTCOMES IN CONJUNCTION WITH OTHER SALVAGE THERAPIES. REPORTED EVENTS: PATIENT 13 EXPIRED 3 MONTHS AFTER LITT DUE TO CARDIAC ARREST PATIENT 15 EXPIRED 7 MONTHS AFTER LITT DUE TO UROSEPSIS ONE PATIENT (1/19, 5.3%) EXPERIENCED IMMEDIATE POST-OPERATIVE MORBIDITY PATIENT 10 DEVELOPED INCREASED EDEMA PERILESIONALLY ON POST-PROCEDURE DAY 2 (FIGURE 4) AND ULTIMATELY DEVELOPED RIGHT-SIDED FOOT DROP AND SYMPTOMS OF CHRONIC CAUDA EQUINA DUE TO PROGRESSION OF DISEASE 2 YEARS POST-PROCEDURALLY AFTER METASTATIC SPREAD OF NON-SMALL CELL LUNG CANCER TO THE SPINAL CORD. THE PATIENT ULTIMATELY EXPIRED 25 MONTHS AFTER UNDERGOING LITT. ONLY A SINGLE PATIENT (1/19; 5.3%) EXPERIENCEDPOST-OPERATIVE MORTALITY WITHIN THE FIRST 30 DAYS OF LITT THERAPY DUE TO POSTPROCEDURAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834171 VISUALASE SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Death