BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 9735542 15W VISUALASE

    MDR report key: 7732254 · Received July 30, 2018

    Report

    Report Number
    1723170-2018-03746
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    February 16, 2018
    Report Date
    October 25, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CITATION: KARSY, MICHAEL; PATEL, DAXA M.; BOLLO, ROBERT J. ¿TRAPPED VENTRICLE AFTER LASER ABLATION OF A SUBEPENDYMAL GIANT CELL ASTROCYTOMA COMPLICATED BY INTRAVENTRICULAR GADOLINIUM EXTRAVASATION: CASE REPORT¿. JOURNAL OF NEUROSURGERY: PEDIATRICS, 21, 2018: 523-527. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. THE AUTHOR DID NOT RESPOND TO A REQUEST FOR FURTHER INFORMATION. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PARTS RETURNED.

    Additional Manufacturer Narrative · 1

    PER AUTHOR, THE ADVERSE EVENT LISTED IN ARTICLE WAS NOT RELATED TO MEDTRONIC SYSTEM. IF THIS INFORMATION WAS AVAILABLE PRIOR TO INITIAL FILING, THIS COMPLAINT WOULD NOT BE REPORTED.

    Description of Event or Problem · 1

    SUMMARY: MAGNETIC RESONANCE IMAGING¿GUIDED STEREOTACTIC LASER ABLATION OF INTRACRANIAL TARGETS, INCLUDING BRAIN TUMORS, HAS EXPANDED DRAMATICALLY OVER THE PAST DECADE, BUT THERE HAVE BEEN FEW REPORTS OF COMPLICATIONS, ESPECIALLY THOSE OCCURRING IN A DELAYED FASHION. LASER ABLATION OF SUBEPENDYMAL GIANT CELL ASTROCYTOMAS (SEGAS) IS AN ATTRACTIVE ALTERNATIVE TO MAINTENANCE IMMUNOTHERAPY IN SOME CHILDREN WITH TUBEROUS SCLEROSIS COMPLEX (TSC); HOWEVER, THE EFFECT OF TREATMENT ON DISEASE PROGRESSION AND THE NATURE AND FREQUENCY OF POTENTIAL COMPLICATIONS REMAINS LARGELY UNKNOWN. THE AUTHORS REPORT THE CASE OF A (B)(6)-YEAR-OLD BOY WITH TSC WHO UNDERWENT STEREOTACTIC LASER ABLATION OF A SEGA AT THE RIGHT FORAMEN OF MONRO ON 2 SEPARATE OCCASIONS. AFTER THE SECOND ABLATION, IMMEDIATE POSTTREATMENT MRI REVEALED GADOLINIUM EXTRAVASATION FROM THE TUMOR INTO THE LATERAL VENTRICLE. NINE MONTHS LATER, THE PATIENT PRESENTED WITH PAPILLEDEMA AND DELAYED OBSTRUCTIVE HYDROCEPHALUS SECONDARY TO INTRAVENTRICULAR ADHESIONS CAUSING A TRAPPED RIGHT LATERAL VENTRICLE. THIS WAS SUCCESSFULLY TREATED WITH ENDOSCOPIC SEPTOSTOMY. THE AUTHORS DISCUSS THE POTENTIAL CAUSE AND CLINICAL MANAGEMENT OF A DELAYED COMPLICATION NOT PREVIOUSLY REPORTED AFTER A RELATIVELY NOVEL SURGICAL THERAPY. REPORTED EVENTS: (B)(6) YEAR OLD BOY WITH HISTORY OF TSC, EPILEPSY, AND AUTISM WITH BILATERAL SEGAS ACHIEVED SUBTOTAL ABLATION, WITHOUT PROCEDURAL COMPLICATIONS, DURING STEREOTACTIC LASER ABLATION. EIGHTEEN MONTHS POST ABLATION, SIGNIFICANT INTERVAL GROWTH OF THE RESIDUAL TUMOR WAS NOTED. A SECOND LASER ABLATION WAS PERFORMED. IMMEDIATE POSTTREATMENT MRI DEMONSTRATED NEAR-COMPLETE ABLATION OF THE TUMOR BUT ALSO HYPERSENSITIVITY OF THE RIGHT LATERAL VENTRICLE ON POSTCONTRAST FLAIR IMAGING, CONSISTENT WITH GADOLINIUM EXTRAVASATION INTO THE VENTRICLE. NONCONTRAST CT SCANNING THE DAY AFTER THE PROCEDURE CONFIRMED THE ABSENCE OF INTRAVENTRICULAR HEMORRHAGE AND THAT THE MRI-DEMONSTRATED SIGNAL ABNORMALITY WITHIN THE RIGHT VENTRICLE WAS GADOLINIUM. NINE MONTHS AFTER THE SECOND ABLATION, THE PATIENT WAS EVALUATED BY HIS OPHTHALMOLOGIST, WHO NOTED BILATERAL PAPILLEDEMA. MRI DEMONSTRATED A SIGNIFICANTLY DECREASED SIDE OF THE RIGHT-SIDED SEGA BUT THERE WAS A TRAPPED RIGHT LATERAL VENTRICLE WITH OBSTRUCTIVE HYDROCEPHALUS. THE PATIENT WAS TREATED WITH ENDOSCOPIC SEPTOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573656 SYSTEM 9735542 15W VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention