BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 11667445 · Received April 14, 2021

    Report

    Report Number
    3009453079-2021-00170
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 24, 2021
    Report Date
    December 14, 2021
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021, FOR WOUND DEBRIDEMENT, CRANIUM HARDWARE (PLATE) REMOVAL, AND WOUND CLOSURE. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THE EVENT WAS COMPLICATED BY A WOUND INFECTION THAT WAS TREATED WITH ANTIBIOTICS (LINEZOLID/CIPROFLOXACIN/CEFTRIAXONE) TO GOOD EFFECT. ON (B)(6) 2021, THE PATIENT UNDERWENT WOUND DEBRIDEMENT WITH ROTATIONAL FLAP CLOSURE. ON (B)(6) 2021, OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2021, THE PRESCRIBER NOTED THAT THE SCALP WOUND WAS APPROXIMATELY AN ERASER SIZED OPEN AREA AT THE RIGHT FRONTAL SCALP. WOUND BORDERS WERE SMOOTH WITHOUT SIGNS OF INFECTION OR ABSCESS. THE PATIENT WAS INSTRUCTED TO RE-START OPTUNE THERAPY WITH A NEW TRANSDUCER ARRAY LAYOUT MAPPED TO AVOID THE NON-HEALING OPEN AREA ON THE SCALP. DURING AN OFFICE EXAMINATION ON (B)(6) 2021, THE PRESCRIBER NOTED THE RIGHT FRONTAL WOUND APPEARED SLIGHTLY LARGER. ON (B)(6) 2021, NOVOCURE RECEIVED A REPORT THAT THE PATIENT'S WOUND RE-OPENED AND BECAME WORSE. ON (B)(6) 2021, PATIENT REPORTED HE ENDED OPTUNE THERAPY. ON (B)(6) 2021, PRESCRIBING PHYSICIAN ASSESSED THE CAUSE OF THE EVENT TO PRESSURE FROM OPTUNE ON THE SCALP AND PATIENT USING THE DEVICE REGULARLY FOR A NUMBER OF MONTHS AT HIGH PROPORTIONS. PREVIOUS BEVACIZUMAB COULD HAVE ALSO CONTRIBUTED. NOVOCURE'S OPINION IS THAT A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE WOUND DEHISCENCE AND WOUND INFECTION CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR WOUND INFECTION AND WOUND DEHISCENCE IN THIS PATIENT INCLUDE HISTORY OF CONCOMITANT BEVACIZUMAB (VEGF INHIBITOR WHICH CARRIES A BLACK BOX WARNING FOR WOUND HEALING COMPLICATIONS. SOURCE: BEVACIZUMAB PRESCRIBING INFORMATION), PRIOR RADIATION, UNDERLYING CANCER DISEASE AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. WOUND INFECTION IS AN EXPECTED EVENT WITH DEVICE USE AND WAS REPORTED AS AN ADVERSE EVENT IN THE EF-14 TRIAL OF OPTUNE TOGETHER WITH TEMOZOLOMIDE (TMZ) COMPARED TO TMZ ALONE IN PATIENTS WITH NEWLY DIAGNOSED GBM IN BOTH ARMS OF THE TRIAL (<1% AND <1% IN OPTUNE/TMZ AND TMZ ARMS RESPECTIVELY). WOUND DEHISCENCE WAS REPORTED IN THE OPTUNE/TMZ ARM OF THE TRIAL (<1%) ONLY.

    Additional Manufacturer Narrative · 1

    NOVOCURE'S OPINION IS THAT A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE ULCERATION CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR MEDICAL DEVICE SITE ULCER IN THIS PATIENT INCLUDE CONCOMITANT BEVACIZUMAB (VEGF INHIBITOR WHICH CARRIES A BLACK BOX WARNING FOR WOUND HEALING COMPLICATIONS. SOURCE: BEVACIZUMAB PRESCRIBING INFORMATION), PRIOR RADIATION, UNDERLYING CANCER DISEASE AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. MEDICAL DEVICE SITE ULCER IS AN EXPECTED EVENT WITH DEVICE USE AND WAS REPORTED AS AN ADVERSE EVENT IN THE EF-14 TRIAL OF OPTUNE TOGETHER WITH TEMOZOLOMIDE (TMZ) COMPARED TO TMZ ALONE IN PATIENTS WITH NEWLY DIAGNOSED GBM IN THE OPTUNE ARM OF THE TRIAL (<1%).

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2019. PER MEDICAL RECORDS, ON (B)(6) 2020, PRESCRIBING PHYSICIAN NOTED THAT THE PATIENT HAD DEVELOPED AN ULCER ON THE SCALP NEAR THE CRANIOTOMY SURGICAL RESECTION SITE (LAST SURGICAL RESECTION (B)(6) 2018). THE PATIENT WAS INSTRUCTED TO TEMPORARILY DISCONTINUE OPTUNE THERAPY, CONTINUE TREATING THE AFFECTED AREA WITH A TOPICAL OINTMENT (MUCIPROCIN), AND CONSULT WITH DERMATOLOGY FOR FURTHER TREATMENT. ON (B)(6) 2020, DURING A SCALP RE-CHECK APPOINTMENT, IT WAS NOTED THAT THE ULCERATIVE LESION HAD SCABBED BUT REMAINED RAISED. A NEW TRANSDUCER ARRAY MAP PRESCRIPTION WAS PROVIDED TO AVOID THE RAISED AREA ON THE SCALP AND THE PATIENT RESUMED OPTUNE THERAPY IN (B)(6) 2021. ON (B)(6) 2021, THE PATIENT PRESENTED FOR EVALUATION DUE TO RE-OPENING OF THE SCALP LESION WITH EXPOSED CRANIUM SURGICAL MESH, SURROUNDING ERYTHEMA, THICK GREEN DRAINAGE AND SLOUGH WITHIN THE WOUND BED. SCALP WOUND DRESSINGS HAD BEEN REMOVED AND CHANGED EVERY 3 DAYS ALONG WITH THE TRANSDUCER ARRAYS. ON (B)(6) 2021, NEUROSURGERY NOTES DESCRIBED SKIN BREAKDOWN OF THE SCALP MEASURING APPROXIMATELY 3 TO 4 CM IN DIAMETER WITHOUT ERYTHEMA OR PURULENCE. THE PATIENT DENIED RECENT FEVERS, HEADACHES, SEIZURES OR MENTAL STATUS CHANGES. NEUROSURGERY DETERMINED THAT THE PATIENT WOULD NEED WOUND REVISION SURGERY TO REMOVE THE CRANIUM HARDWARE AND DEBRIDE THE WOUND AREA. PRESCRIBING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561874 OPTUNE OPTUNE NZK NOVOCURE GMBH TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H BEVACIZUMAB.| CARVEDILOL.| LEVETIRACETAM.| LISINOPRIL.| ONDANSETRON.| RIVAROXABAN.| RIVAROXABAN.| SIMVASTATIN.| SYNTHETIC CANNABINOIDS.| TEMOZOLOMIDE.| TRAZODONE.