BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6598775 · Received May 30, 2017

    Report

    Report Number
    1723170-2017-02209
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    May 21, 2015
    Report Date
    May 30, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT IDENTIFIER NOT AVAILABLE FROM THE JOURNAL ARTICLE AUTHORS. PATIENT AGE PROVIDED WAS THE MEAN AGE PROVIDED IN THE JOURNAL ARTICLE. PATIENT SEX PROVIDED SELECTED AS MALE AS THERE WERE 4 WOMEN AND 11 MALES. PATIENT WEIGHT NOT AVAILABLE FROM THE JOURNAL ARTICLE AUTHORS. EVENT DATE IS APPROXIMATED. THE DATE PROVIDED WAS THE DATE OF ONLINE PUBLICATION. CITATION: HERMANN, EJ., PETRAKAKIS, I., POLEMIKOS, M., RAAB, P., CINIBULAK, Z., NAKAMURA, M., & KRAUSS, JK. ELECTROMAGNETIC NAVIGATION-GUIDED SURGERY IN THE SEMI-SITTING POSITION FOR POSTERIOR FOSSA TUMOURS: A SAFETY AND FEASIBILITY STUDY. ACTA NEUROCHIR (2015) 157:1229¿1237. DOI 10.1007/S00701-015-2452-2. ONE MDR WAS FILED FOR ALL 15 PATIENTS AS THE AMOUNT OF INACCURACY PER SPECIFIC PATIENT WAS NOT REPORTED IN THE JOURNAL ARTICLE NOR WAS IT MADE CLEAR IF ALL PATIENTS EXPERIENCED INACCURACY DURING NAVIGATION. PER THE JOURNAL ARTICLE, POSTERIOR FOSSA LESIONS MAY BE CHALLENGING FOR SURGERY, ESPECIALLY WHEN THEY ARE SMALL AND DEEP-SEATED INVOLVING MIDLINE STRUCTURES LIKE THE BRAINSTEM, THE CEREBELLAR PEDUNCLES OR THE TEGMENTAL MESENCEPHALIC REGION. BRAINSHIFT IS THE MOST VEXING PROBLEM IN NEURONAVIGATION. NAVIGATION IN THE SEMI-SITTING POSITION IS ESPECIALLY CHALLENGING BECAUSE OF THE ADDITIONAL IMPACT OF GRAVITY AND THE DOWNWARD DISPLACEMENT OF THE CEREBELLAR HEMISPHERES AFTER OPENING OF THE DURA AND CSF RELEASE. ACCURACY OF NAVIGATION WAS SHOWN TO DIFFER BETWEEN THE FRONTAL REGION AND THE OCCIPITAL REGION. SURFACE-BASED REGISTRATION ACCURACY WAS SHOWN TO BE BETTER IN THE FACE AND IN THE FRONTAL REGION, AND ERROR INCREASED AS THE TARGET LOCATION WAS FURTHER AWAY FROM THE FACE. EM-GUIDED NEURONAVIGATION IN THE SEMI-SITTING POSITION FOR POSTERIOR FOSSA TUMOURS WAS BOTH SAFE AND TECHNICALLY FEASIBLE. 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. NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROMAGNETIC (EM) NAVIGATION SYSTEM WAS USED AND A MEDTRONIC WORK STATION WAS USED FOR PREOPERATIVE 3D RECONSTRUCTIONS. INACCURACIES WERE MENTIONED DURING TUMOR RESECTION DURING THE USE OF THE NAVIGATION SYSTEM. OVER A PERIOD OF 40 MONTHS, NAVIGATIONAL GUIDANCE WAS THOUGHT TO BE USEFUL IN A SUBSET OF 15 PATIENTS AFTER THOROUGH STRATEGICAL PREOPERATIVE DISCUSSION. THERE WERE FOUR WOMEN AND 11 MEN. THE STUDY INCLUDED SIX CHILDREN AND NINE ADULTS. MEAN AGE AT SURGERY WAS 34.6 YEARS (RANGE, 8¿84 YEARS). INCLUSION CRITERIA WERE PRIMARILY SMALL OR DEEP-SEATED LESIONS INVOLVING MIDLINE OR PARAMEDIAN STRUCTURES THOUGHT TO BE DIFFICULT FOR INTRAOPERATIVE IDENTIFICATION, AND ALSO RECURRENT TUMOURS, SUPPOSED NOT TO BE MARKEDLY AFFECTED BY BRAINSHIFT AND GRAVITATION AFTER OPENING OF THE DURA AND RELEASING CEREBROSPINAL FLUID (CSF). WHILE WE RELIED ON FIDUCIALS FIXED TO THE OSSEOUS SKULL IN OUR INITIAL STUDY [22], WE SUBSEQUENTLY USED SURFACE-RENDERING OF THE FACE AS OUTLINED IN DETAIL ELSEWHERE. THE DYNAMIC REFERENCE FRAME (DRF) WAS ATTACHED TO THE FOREHEAD JUST ABOVE THE EYEBROW AND REGISTRATION WAS ACHIEVED BY SURFACE MATCHING. ACCURACY WAS CONFIRMED BY CHECKING SURFACE MARKERS OF THE SKULL. TO BETTER ACCOUNT FOR TOTAL SPATIAL INACCURACY ALSO A RESULTING VECTOR WAS CALCULATED FROM THE CARTESIAN COORDINATES X, Y AND Z IN MILLIMETRES. AFTER, THE PATIENT¿S HEAD WAS FIXED IN THE MAYFIELD CLAMP, THE PATIENT¿S POSITION WAS CHANGED THEN FROM SUPINE TO THE SEMI-SITTING POSITION FOR SURGERY WITH THE HEAD IN ANTEFLEXION TO GAIN ACCESS TO THE POSTERIOR FOSSA. FIRST, A CUSTOMISED CRANIOTOMY WAS PERFORMED GUIDED BY EM NAVIGATION AS NEEDED TO APPROACH THE PATHOLOGICAL PROCESS TAKING THE LOCATION OF THE DURAL SINUSES INTO ACCOUNT. AFTER REMOVAL OF THE BONE FLAP AND BEFORE OPENING THE DURA, THE EM NAVIGATION STYLET WITH THE VIRTUAL TIP EXTENSION WAS USED TO ASSESS PRECISELY THE DIRECTION AND THE DISTANCE TO THE TARGET LESION, AND ALSO TO CONFIRM THE LOCATION OF THE VENOUS SINUSES. THEN, AFTER MICROSURGICAL OPENING OF THE DURA AND CSF RELEASE, THE EM STYLET WAS USED AGAIN FOR ORIENTATION, TAKING INTO ACCOUNT THE TRAJECTORY, BEFORE OPENING THE DURA (SCREEN SHOT). THIS HELPED TO ASSESS AND CORRECT FOR THE AMOUNT OF BRAINSHIFT. THE SURGEON ALTERNATED SEVERAL TIMES BETWEEN MICROSURGICAL PREPARATION UNDER MICROSCOPICAL VIEW AND ON-LINE TRACKING NAVIGATION OF THE TIP OF THE EM STYLET TO CHECK THE DISTANCE AND TO CONTROL THE DIRECTION TO THE TARGET LESION. ONCE THE TARGET LESION WAS REACHED BY MICROSCOPICAL VIEW, THE TIP OF THE EM STYLET WAS POSITIONED ON IT, AND THE ACTUAL POSITION WAS COMPARED WITH THE POSITION DISPLAYED ON THE NAVIGATION SCREEN. BOTH SETS OF INFORMATION, BASED ON THE MICROSCOPICAL VIEW AND THE POSITION AS OUTLINED ON THE SYNTHESISED TAKING THE AMOUNT OF BRAINSHIFT INTO ACCOUNT. EM NAVIGATION FOR SURGERY IN THE SEMI-SITTING POSITION WAS FEASIBLE IN ALL 15 SELECTED CASES. THE LOCATION OF THE VENOUS SINUSES WAS RELIABLY CONFIRMED. IDENTIFICATION OF THE TARGET LESION USING THE EM NAVIGATION WAS ACHIEVED IN ALL INSTANCES. THE OVERALL MEAN DEVIATION OF EM NAVIGATION ACCURACY (RESULTING VECTOR) FOR ANATOMICAL LANDMARKS WAS 2.48 MM (± 0.75 MM) IN THE SUPINE POSITION AND 2.5 MM (± 0.92 MM) AFTER REPOSITIONING OF THE PATIENT IN THE SEMI-SITTING POSITION FOR SURGERY, WHICH WAS STATISTICALLY NOT SIGNIFICANT (P=0.44). SEE TABLE 2 AND TABLE 3. THE DEVIATION OF NAVIGATION ACCURACY FOR THE SURFACE OF THE TARGET LESION RANGED BETWEEN 2.5 AND 5.8 MM (MEAN, 3.88 ± 1.15). BRAIN SHIFT DURING SURGERY WAS REMARKABLE FOR THE CEREBELLAR HEMISPHERES DUE TO GRAVITY AND LOSS OF CSF. POSTOPERATIVE IMAGING WAS OBTAINED ROUTINELY 6 H AFTER SURGERY TO RULE OUT POSTOPERATIVE COMPLICATIONS LIKE BLEEDING, INFARCTION, BRAIN SWELLING, HYDROCEPHALUS OR PNEUMOCEPHALUS. THERE WERE NO COMPLICATIONS RELATED TO THE APPLICATION OF THE EM NAVIGATION SYSTEM. ALSO, THERE WERE NO LINE-OF-SIGHT PROBLEMS. THE USE OF THE EM NAVIGATION SYSTEM INTERFERED WITH MONITORING OF EVOKED POTENTIALS. RELIABLE MONITORING WAS ONLY POSSIBLE AFTER TEMPORARY REMOVAL OF THE TRANSMITTER COIL FROM THE DESK-HOLDER SINCE IT PRODUCED ARTIFACTS. THEREFORE, DURING NAVIGATION MONITORING WAS STOPPED. WHENEVER EM NAVIGATION WAS REQUESTED, EASY REPOSITIONING OF THE TRANSMITTER COIL IN THE DESK-HOLDER WAS FEASIBLE. THE METALLIC WOUND RETRACTOR IMPAIRED ACCURATE IDENTIFICATION OF THE TIP OF THE EM STYLET AT THE BEGINNING OF THE OPERATION BEFORE PERFORMING THE CRANIOTOMY. EM NAVIGATION WITH THE TIP OF THE EM STYLET IN THAT PHASE THEREFORE WAS ONLY POSSIBLE AFTER TEMPORARY REMOVAL OF THE RETRACTOR. WITH THE OPERATION PROCEEDING MORE TO THE DEPTH, HOWEVER, AFTER REMOVAL OF THE BONE FLAP NO MORE INTERFERENCES OCCURRED, SO THAT THERE WAS NO NEED TO REMOVE THE WOUND RETRACTOR. OVERALL, THE PRESENT STUDY DEMONSTRATED THAT EM NAVIGATION IN THE SEMI-SITTING POSITION WAS A USEFUL ADJUNCT TO LOCALISE SMALL OR DEEP SEATED TUMOURS IN THE BRAINSTEM, THE CEREBELLAR PEDUNCLES AND THE MIDBRAIN. BRAINSHIFT AFTER CSF LOSS WAS NOT A MAJOR PROBLEM, AS DEMONSTRATED ALSO BY MEASUREMENTS AT THE OBEX AND THE MEDIAN SULCUS ON THE FLOOR OF THE FOURTH VENTRICLE. EM NAVIGATION ALLOWED A COMFORTABLE REGISTRATION PROCEDURE FOR THE PATIENT BY SURFACE MATCHING OF THE FACE IN A SUPINE POSITION. SUFFICIENT ACCURACY WAS DEMONSTRATED WHEN SURFACE LANDMARKS WERE RECHECKED AFTER DEFINITIVE POSITIONING OF THE PATIENT FOR SURGERY IN THE SEMI-SITTING POSITION. REFERENCING OF THE SYSTEM WAS EASY WITHOUT ANY LINE-OF-SIGHT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378922 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR