BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6691418 · Received July 6, 2017

    Report

    Report Number
    1723170-2017-02759
    Event Type
    Death
    Date Received
    July 6, 2017
    Date of Event
    December 12, 2012
    Report Date
    July 6, 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
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT MADE AVAILABLE FROM THE JOURNAL ARTICLE AUTHORS. CITATION: VISOCCHI, M., SIGNORELLI, F., LIAO, C., RIGANTE, M., PALUDETTI, G., BARBAGALLO, G., OLIVI, A. ENDOSCOPIC ENDONASAL APPROACH FOR CRANIOVERTEBRAL JUNCTION PATHOLOGIC CONDITIONS: MYTH AND TRUTH IN CLINICAL SERIES AND PERSONAL EXPERIENCE. WORLD NEUROSURG. (2017) 101:122-129. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2017.01.099. THE JOURNAL ARTICLE REPORTS THAT THE INTRAOPERATIVE CSF LEAK WAS PROBABLY A RESULT OF THE LIMITATION OF THE BIDIMENSIONAL VIEW WITH AN OBLIQUE SURGICAL VIEW OF ANENDOSCOPIC ENDONASAL APPROACH (EEA) INSTEAD OF THE TRIDIMENSIONAL TRANSORAL MICROSURGICAL VIEW WITH A STRAIGHTFORWARD SURGICAL VIEW OF TOA. NO POSSIBLE OTHER EXPLANATIONS (E.G., MEDICAL HISTORY, INDIVIDUAL RISK FACTORS) SHOULD BE GIVEN TO BETTER UNDERSTAND THE UNFAVORABLE CLINICAL COURSE OF THE PATIENT. NO DOUBT THAT ¿THE TRANSNASAL ENDOSCOPIC APPROACH BEING ABOVE THE LEVEL OF SOFT PALATE SHOULD EXPOSE TO A LOWER DEGREE OF BACTERIAL CONTAMINATION¿; NEVERTHELESS, DIFFERENT FROM THE OTHER 5 PATIENTS, PATIENT 1 PRESENTED WITH AN INTRAOPERATIVE COMPLICATION (CSF FISTULA). THE DOUBLESTAGED APPROACH WITH HALO VEST IMMOBILIZATION FOR 1 WEEK, ALONG WITH UNRECOGNIZED PERSISTING CSF LEAKAGE, DELAYED IDENTIFICATION OF THIS COMPLICATION (PROBABLY BECAUSE OF THE DIFFICULTY IN PROVOKING NOSE LEAKAGE WITH THE QUECKENSTEDT TEST), AS WELL THE INSTIGATION OF MEDICAL (ANTIBIOTICS) AND SURGICAL (EXTERNAL DRAINAGE) THERAPIES. THE ARTICLE ALSO REPORTS THAT THE SURGICAL TREATMENT OF CVJ REMAINS CHALLENGING BECAUSE OF THE COMPLEX ANATOMIC AND BIOMECHANICAL CHARACTERISTICS OF THE REGION. THE AUTHORS STRONGLY SUPPORT THE NEED: TO AVOID AS MUCH AS POSSIBLE DURAL TEARS BY OVERCOMING THE LEARNING CURVE AND; TO PERFORM A 1-STAGE COMBINED ANTERIOR AND POSTERIOR APPROACH TO ALLOW EARLIER IDENTIFICATION OF POSSIBLE CSF FISTULA WITHOUT THE OBSTACLE OF THE HALO VEST AND TO IMMEDIATELY START ADEQUATE THERAPIES WITHOUT ANY DELAY. BASED ON CLINICAL KNOWLEDGE, INFECTION AND CEREBROSPINAL FLUID (CSF) LEAK IS AN INHERENT RISK OF THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. 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. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY A MEDTRONIC REPRESENTATIVE. USE OF THE NAVIGATION SYSTEM (NEURONAVIGATION) WAS REPORTED. FROM 2011 TO DATE, A CONSECUTIVE SERIES OF 6 PATIENTS WITH VARIED CRANIOVERTEBRAL JUNCTION (CVJ) DISEASES HAVE BEEN TREATED WITH ANENDOSCOPIC ENDONASAL APPROACH (EEA) APPROACH WITH THE USE OF THE INTRAOPERATIVE NEURONAVIGATION AND TWO-DIMENSIONAL ENDOSCOPY (KARL STORZ, (B)(4)) WERE USED. IN ALL CASES, THE 4-HANDED TECHNIQUE VIA 2 NOSTRILS WAS USED TO RESECT THE CVJ DISEASE. AFTER A MIDLINE INCISION OF THE MUCOSA, THE ANTERIOR ARCH OF C1 AND THE ODONTOID PROCESS WERE REMOVED BY USING A HIGH-SPEED DRILL AND ULTRASONIC SURGICAL ASPIRATOR (SONOPET ULTRASONIC ASPIRATOR). THE CVJ DURA MATER WAS DECOMPRESSED. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED INTRAOPERATIVELY AND POSTOPERATIVELY (CEFAZOLINE 2 G/DAY). PATIENTS FIXED IN A HALO VEST WERE TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE THEY STAYED USUALLY FOR 48-72 HOURS. A SUBSEQUENT SHORT OCCIPITOCERVICAL INSTRUMENTATION AND FUSION PROCEDURE WAS COMPLETED FOR CVJ TUMORS IN LINE WITH PATIENT'S WISHES (NO MENTION OF MEDTRONIC PRODUCT FOR THIS PROCEDURE). THE LENGTH OF FOLLOW-UP OF OUR PATIENTS RANGES FROM 1 TO 48 MONTHS (TABLE 1); ALL PATIENTS IMPROVED OR REMAINED UNCHANGED (IN GOOD NEUROLOGIC STATUS) AFTER SURGERY AND DURING FOLLOW-UP, HAVING AN UNCOMPLICATED POSTOPERATIVE COURSE. ALL PATIENTS, EXCEPT PATIENT 1, WERE DISCHARGED AFTER POSTERIOR INSTRUMENTATION AND FUSION PROCEDURES WITHIN 2 WEEKS OF ADMISSION. ONLY IN PATIENT 1, PRESENTING WITH A BASILAR IMPRESSION, AN INTRAOPERATIVE CEREBROSPINAL FLUID (CSF) LEAK OCCURRED ON (B)(6) 2012, REQUIRING AN IMMEDIATE SURGICAL REPAIR WITH A MUCOSA PEDICLE FLAP. THE PATIENT IMPROVED AFTER SURGERY WITHIN 48 HOURS AND WAS ABLE TO WALK AND FEED HERSELF WITHOUT THE NEED OF ANY ASSISTANCE FOR 10 DAYS; NEVERTHELESS, SHE SUBSEQUENTLY RAPIDLY DETERIORATED AND DIED 1 MONTH AFTER SURGERY ON (B)(6) 2013, 30 DAYS AFTER. BECAUSE THE PATIENT WAS IMMOBILIZED WITH A HALO VEST, CSF NOSE LEAKAGE WAS NOT EVIDENT SPONTANEOUSLY OR WITH A JUGULAR COMPRESSION TEST (QUECKENSTEDT TEST). ANHYPERINTENSITY ON BULBOMEDULLARY JUNCTION WAS EVIDENT ON MAGNETIC RESONANCE IMAGING (MRI) IMAGES ON (B)(6) (9 DAYS LATER, 1 DAY BEFORE INSTRUMENTATION AND FUSION PROCEDURE). DURING THE SUBSEQUENT POSTERIOR FIXATION PROCEDURE PERFORMED ON (B)(6) 2012, IN A PRONE POSITION, CSF LEAKAGE WAS EVIDENT IN THE OPERATING ROOM AND EXTERNAL CSF EXTERNAL DRAINAGE WAS PERFORMED AND LEFT FOR 5 DAYS FOLLOWED BY STABLE CONTROL OF THE LEAKAGE. ON (B)(6), 2 DAYS AFTER POSTERIOR INSTRUMENTATION AND FUSION A PROGRESSIVE TONSILLAR AND CEREBELLAR HEMISPHERIC T2 HYPERINTENSITY WAS EVIDENT ON MRI. POSTOPERATIVELY, THE PATIENT DEVELOPED MENINGOENCEPHALITIS CONFIRMED BY POSITIVE CSF CULTURES FOR FUNGI (CANDIDA ALBICANS), WHICH, DESPITE APPROPRIATE ANTIMYCOTIC THERAPY (MICAFUNGIN, 5-FLUOROCYTOSINE) PROGRESSIVELY WORSENED, LEADING TO THE PATIENT'S FATAL NEUROLOGIC COMPLICATIONS. NEURONAVIGATION HAS PROVED TO BE AN IMPORTANT ADJUNCT. IMAGE GUIDANCE IS A USEFUL TOOL TO VISUALLY RECONSTRUCT THE MAGNIFIED THREE-DIMENSIONAL ANATOMIC IMAGING, ALLOWING INSPECTION OF THE ANATOMIC IMAGES IN MULTIPLE RECONSTRUCTED VIEWS AND PERMITTING A BETTER ORIENTATION DURING THE SURGICAL PROCEDURE. ALTHOUGH THE ERROR ASSOCIATED WITH SPINAL SHIFT IS NOT COMPLETELY ELIMINATED, THE CALCULATED ACCURACY IS LESS THAN 1 MM. A TOTAL OF 107 PATIENTS (INCLUDING OUR 6) AFFECTED BY CVJ DISEASE AND TREATED WITH EEA HAVE BEEN REPORTED IN THE LITERATURE SO FAR. AMONG THESE PATIENTS, A CSF LEAK (INTRAOPERATIVE AND/OR POSTOPERATIVE) WAS REPORTED IN 13 (12.4%). ONLY FATAL COMPLICATION WAS ASSOCIATED WITH EEA. ACCORDING TO THE LITERATURE AND TO OUR PERSONAL EXPERIENCE, THE PRESUMED IMPROVED SAFETY, THE INDICATIONS AND THE ADVANTAGES OF EEA NEED TO BE REASSESSED COMPARED WITH THE ENDOSCOPIC MICROSURGICAL TRANSORAL APPROACH (TOA) TO THE CVJ. NEVERTHELESS, MORE PROSPECTIVE TRIALS NEED TO BE TAKEN INTO CONSIDERATION TO BETTER COMPARE ADVANTAGES AND DISADVANTAGES OF THESE DIFFERENT TOOLS IN THE MODERN ARMAMENTARIUM FOR THIS CHALLENGING AND COMPLEX SURGERY. RECENT SYSTEMATIC REVIEW AND METAANALYSIS SHOWED A MORBIDITY/MORTALITY PREVALENCE OF EEA ON TOA (MORTALITY, 4%-2.9%; INTRAOPERATIVE CSF LEAKS, 30%-0.3%; POSTOPERATIVE CSF LEAK, 5.2%-0.8%; MENINGITIS, 4%-0.4%; NONE OF THESE DIFFERENCES WAS STATISTICALLY SIGNIFICANT. IN CONCLUSION, THE PRESENT STUDY SEEMS TO SUGGEST THAT EEA CAN PRODUCE COMPLICATIONS SIMILAR TO TOA IN CVJ SURGERY, INCLUDING VELOPHARYNGEAL INSUFFICIENCY AND SERIOUS INFECTIONS, AS IN PATIENT 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471636 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| L| R