BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6370776 · Received March 1, 2017

    Report

    Report Number
    1723170-2017-00895
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    August 31, 2014
    Report Date
    June 9, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO ALL THE FOLLOWING AS THESE STATEMENTS WERE INADVERTENTLY LEFT OFF INITIAL MDR. CORRECTION: BRAND NAME, COMMON DEVICE NAME, PROCODE AND SERIAL NUMBER WAS NOT PROVIDED IN ARTICLE. THE ARTICLE MENTIONS A NAVIGATION SYSTEM (MODEL NOT SPECIFIED). FURTHER INFORMATION UNAVAILABLE. THOSE SELECTED ARE SUSPECTED TO BE FOR THE DEVICE USED. CORRECTION: 510K NOT PROVIDED AS THE SPECIFIC SUSPECT NAVIGATION SYSTEM WAS NOT PROVIDED IN THE ARTICLE. THE SELECTED IS SUSPECTED TO BE FOR THE DEVICE USED. CORRECTION: DEVICE MANUFACTURE DATE UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED BY THE JOURNAL ARTICLE AUTHORS. EVENT DATE IS APPROXIMATED AS THE EXACT DATES WERE NOT MADE AVAILABLE. THE PROCEDURES WERE REPORTED TO HAVE OCCURRED THROUGH AUGUST 2014, THEREFORE 8/31/2014, WAS USED. CITATION: THIABPHA, A., HANSASUTA, A. INITIAL EXPERIENCE WITH ULTRA-LOW-FIELD INTRAOPERATIVE MAGNETIC RESONANCE IMAGING IN ENDOSCOPIC ENDONASAL TRANSSPHENOIDAL SURGERY FOR PITUITARY. J MED ASSOC THAI 2016; 99 (SUPPL. 3): S30-S38. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. PER THE ARTICLE, ADVANCE IN STEREOTACTIC NAVIGATION HAS BEEN SHOWN TO AID TUMOR RESECTION IN ADDITION TO SAFE GUIDANCE FOR TSS. HOWEVER, NAVIGATION SYSTEM LACKS REAL-TIME FEEDBACK TO PROPERLY ASSURE SURGEON OF THE COMPLETE PA RESECTION. AS A RESULT, DESPITE SOPHISTICATED SURGICAL DEVICES, RESIDUAL PA AFTER TSS HAS BEEN REPORTED TO BE 15% TO 70%. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UPON FURTHER MULTI-DISCIPLINARY TEAM REVIEW, IT WAS FOUND THAT THERE ARE NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    PER ARTICLE, FORWARDED BY A MEDTRONIC REPRESENTATIVE, THE USE OF THE NAVIGATION SYSTEM AND IMAGING SYSTEM ENDOSCOPIC TRANSSPHENOIDAL SURGERY FOR PITUITARY ADENOMA (PA) WAS REPORTED. THIS IS ONE OF TWO REPORTS. FROM SEPTEMBER 2013 TO AUGUST 2014, A TOTAL OF 29 PATIENTS HAD INTRAOPERATIVE MAGNETIC RESONANCE IMAGING (IMRI) FOR THEIR INTRACRANIAL SURGERIES. THERE WERE 11 PATIENTS THAT MET THE FULL CRITERIA AND THEIR PATIENTS¿ DATA ARE SHOWN IN TABLE 1. A (B)(6) MALE (CASE 1) WITH KNOSP GIANT GRADE 4 NON-FUNCTIONING PITUITARY ADENOMA UNDERWENT ENDOSCOPIC TRANSSPHENOIDAL SURGERY (ETSS) USING IMRI. A RESIDUAL TUMOR WAS FOUND BY POSTOPERATIVE IMRI. DESPITE FURTHERED PA RESECTION, HAD INTRAVENTRICULAR REMNANT DUE TO LACKS OF SUFFICIENTLY LONG INSTRUMENT TO REACH IT. THIS PATIENT, WITH CONCERNS OF NEUROVASCULAR INJURY, ALSO HAD RESIDUAL TUMOR IN CAVERNOUS SINUS, WHICH WE INTENTIONALLY LEFT, DUE TO UNRESECTABLE KNOSP GRADE 4 PA. A LESSON LEARNED FROM OUR FIRST CASE, NO HIGHER THAN KNOSP GRADE 3 WAS SELECTED FOR OUR SUBSEQUENT CASE TO UNDERGO ETSS WITH IMRI. THIS DECISION WAS BASED ON THE FACT THAT ONCE THE TUMOR REACHES BEYOND LATERAL BORDER OF INTERNAL CAROTID ARTERY, IT IS UNLIKELY THAT COMPLETE TUMOR RESECTION CAN BE ACCOMPLISHED WITHOUT UNDUE NEUROVASCULAR RISK. THE FIRST CASE WAS ALSO OUR ONLY PA THAT HAD TREMENDOUS, SUPERIOR, INTRAVENTRICULAR EXTENSION BEYOND FORAMEN OF MONRO WITH A LACK OF SUFFICIENTLY LONG INSTRUMENT TO REACH ITS MARGIN. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150368 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other| R