BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 7037521 · Received November 16, 2017

    Report

    Report Number
    1723170-2017-04701
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    May 4, 2016
    Report Date
    November 16, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE JOURNAL ARTICLE OR AUTHOR. PER TABLE 1, MEAN PATIENT AGE WAS 23.0 ± 26.9, 51% WERE FEMALE AND THEREFORE USED. EVENT DATE IS APPROXIMATED. DATE PROVIDED IS WHEN THE JOURNAL ARTICLE WAS ACCEPTED. CITATION: WILSON, TJ, MCCOY, KE, AL-HOLOU, WN, MOLINA, SL, ET AL. COMPARISON OF THE ACCURACY AND PROXIMAL SHUNT FAILURE RATE OF FREEHAND PLACEMENT VERSUS INTRAOPERATIVE GUIDANCE IN PARIETOOCCIPITAL VENTRICULAR CATHETER PLACEMENT. NEUROSURG FOCUS 41 (3):E10, 2016. DOI: 10.3171/2016.5.FOCUS16159. THE EXACT SYSTEM INFORMATION COULD NOT BE DETERMINED AS IT WAS NOT PROVIDED. HOWEVER, THE SYSTEM LISTED ON THIS FORM WAS AT THE ADDRESS LISTED IN THE ARTICLE DURING THE TIME SOME OF THE SURGERIES WERE COMPLETED AND SUSPECTED TO BE THE SYSTEM USED FOR THE PROCEDURES. DEVICE UDI NOT PROVIDED AS THIS PRODUCT IS NO LONGER MANUFACTURED. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. THE AUTHOR DECLINED TO PROVIDE ADDITIONAL 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. THE AUTHORS CONCLUDE THAT THE USE OF INTRAOPERATIVE GUIDANCE SIGNIFICANTLY IMPROVED THE RATE OF ACCURATE CATHETER PLACEMENT AND REDUCED THE RATE OF PROXIMAL SHUNT FAILURE. VENTRICLE SIZE WAS NOT ASSOCIATED WITH THE ACCURACY OF CATHETER PLACEMENT. IN A PROCEDURE THAT IS FRAUGHT WITH A HIGH FAILURE RATE, WE BELIEVE THESE DATA SUPPORT THE ROUTINE USE OF INTRAOPERATIVE GUIDANCE TO IMPROVE PARIETOOCCIPITAL CATHETER ACCURACY AND TO REDUCE PROXIMAL SHUNT FAILURE. THE AUTHORS REPORT THAT IT IS NOT CLEAR WHETHER, WHEN UTILIZING A PARIETOOCCIPITAL APPROACH, IT IS INHERENTLY MORE DIFFICULT TO ACHIEVE ACCURATE CATHETER PLACEMENT OR WHETHER THE TRAJECTORY OF THE CATHETER OR ULTIMATE TARGET FOR THE CATHETER TIP IS ANY MORE OR LESS LIKELY TO LEAD TO PROXIMAL CATHETER FAILURE. THIS STUDY WAS IN LINE WITH PREVIOUS REPORTS SUGGESTING THAT APPROXIMATELY ONE-THIRD OF PATIENTS WILL EXPERIENCE FAILURE OF THE CSF SHUNT. THE STUDY REPORTS SHUNT FAILURES AND INACCURACIES. BASED ON CLINICAL KNOWLEDGE OF SHUNT FAILURES, MOST, IF NOT ALL OF THESE FAILED SHUNTS WOULD HAVE REQUIRED REPOSITIONING OR REPLACEMENT, ALTHOUGH NOT MENTIONED IN THE JOURNAL ARTICLE AS THIS WAS NOT THE PURPOSE OF THE ARTICLE, THEREFORE REPORTING THIS AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE WAS FORWARDED BY A MEDTRONIC REPRESENTATIVE. USE OF THE NAVIGATION SYSTEM WAS REPORTED BETWEEN JANUARY 2005 AND DECEMBER 2013 AT TWO INSTITUTIONS. THIS WAS A RETROSPECTIVE COHORT STUDY. A TOTAL OF 257 PATIENTS WERE INCLUDED: 134 FROM THE UNIVERSITY OF MICHIGAN AND 123 FROM WASHINGTON UNIVERSITY IN ST. LOUIS, INCLUDING BOTH ADULT AND PEDIATRIC PATIENTS. THE SITE USED, WAS THE CORRESPONDENCE AUTHOR'S LOCATION NOTED IN THE ARTICLE. THE AIM OF THIS PAPER IS TO COMPARE THE ACCURACY OF THE FREEHAND TECHNIQUE VERSUS THE USE OF INTRAOPERATIVE GUIDANCE (EITHER ULTRASOUND GUIDANCE OR FRAMELESS STEREOTAXY) FOR PLACEMENT OF PARIETOOCCIPITAL VENTRICULAR CATHETERS AND TO DETERMINE FACTORS ASSOCIATED WITH REDUCED PROXIMAL SHUNT FAILURE. THE MAJORITY OF INTRAOPERATIVE GUIDANCE CAME IN THE FORM OF FRAMELESS STEREOTAXY (93 OF 101 GUIDED CATHETERS), WHILE THE MINORITY WERE PLACED USING ULTRASONIC GUIDANCE (8 OF 101 GUIDED CATHETERS). THUS, THIS STUDY IS MOST DIRECTLY GENERALIZABLE TO INTRAOPERATIVE GUIDANCE USING FRAMELESS STEREOTAXY. ALTHOUGH CEREBROSPINAL FLUID DIVERSION BY WAY OF VENTRICULOPERITONEAL SHUNTING IS A COMMONLY PERFORMED NEUROSURGICAL PROCEDURE, HIGH RATES OF SHUNT FAILURE IS COMMON. UP TO ONE-THIRD OF ADULT PATIENTS UNDERGOING CSF SHUNTING WILL EXPERIENCE A SHUNT FAILURE. MECHANICAL OBSTRUCTION IS THE MOST COMMON REASON FOR FAILURE, AND IN PROXIMAL CATHETER FAILURE, THIS TYPICALLY MEANS OBSTRUCTION BY THE CHOROID PLEXUS. OPTIMAL CATHETER PLACEMENT MAY HELP REDUCE THE RATE OF PROXIMAL FAILURE. INTRAOPERATIVE GUIDANCE (EITHER ULTRASOUND OR STEREOTACTIC NEURONAVIGATION) WAS USED IN 39.3% OF CASES. WHEN INTRAOPERATIVE GUIDANCE WAS USED, 81.2% OF CATHETERS WERE PLACED ACCURATELY COMPARED WITH ONLY 67.3% OF CATHETERS PLACED BY FREEHAND TECHNIQUE. ACCURATE CATHETER PLACEMENT OCCURRED IN 4 OF 8 (50.0%) CASES IN WHICH ULTRASONOGRAPHY WAS USED, 78 OF 93 (83.9%) CASES IN WHICH STEREOTACTIC NEURONAVIGATION WAS USED, AND 105 OF 156 (67.3%) CASES IN WHICH THE FREEHAND TECHNIQUE. WHEN INTRAOPERATIVE GUIDANCE WAS USED, ACCURATE CATHETER PLACEMENT WAS 2.809 TIMES AS LIKELY AS WHEN INTRAOPERATIVE GUIDANCE WAS NOT USED. DURING THE STUDY PERIOD, 108 PATIENTS (42.0%) EXPERIENCED SHUNT FAILURE, 79 PATIENTS (30.7%) HAD FAILURE INVOLVING THE PROXIMAL CATHETER, AND 53 PATIENTS (20.6%) HAD DISTAL FAILURE (VALVE OR DISTAL CATHETER). INTRAOPERATIVE GUIDANCE WAS USED FOR 101 PATIENTS; 20 (19.8%) OF THESE PATIENTS EXPERIENCED A PROXIMAL SHUNT FAILURE. AFTER MULTIVARIATE ANALYSIS, AGE, ACCURATE CATHETER PLACEMENT, AND INTRAOPERATIVE GUIDANCE REMAINED SIGNIFICANTLY ASSOCIATED WITH THE LIKELIHOOD OF PROXIMAL CATHETER FAILURE. FOR EVERY YEAR OF INCREASED AGE, PATIENTS WERE 0.978 TIMES AS LIKELY TO BE PROXIMAL SHUNT FAILURE FREE (95% CI 0.966¿0.990). WHEN INTRAOPERATIVE GUIDANCE WAS USED, PATIENTS WERE 2.485 TIMES AS LIKELY TO BE FREE FROM PROXIMAL CATHETER FAILURE (95% CI 1.227¿5.032). ACCURATE CATHETER PLACEMENT MADE PATIENTS 3.424 TIMES AS LIKELY TO BE FREE FROM PROXIMAL CATHETER FAILURE. YOUNGER AGE WAS ASSOCIATED WITH AN INCREASED LIKELIHOOD OF ACCURATE CATHETER PLACEMENT, WHILE THE USE OF INTRAOPERATIVE GUIDANCE WAS ALSO ASSOCIATED WITH ACCURATE CATHETER PLACEMENT (TABLE 3). OLDER PATIENTS WERE LESS LIKELY TO BE FREE OF PROXIMAL FAILURE, WHILE THE USE OF INTRAOPERATIVE GUIDANCE AND ACCURATE CATHETER PLACEMENT SIGNIFICANTLY REDUCED THE RATE OF PROXIMAL CATHETER FAILURE. THUS, THESE DATA SUGGEST THAT THE IMPROVEMENT IN ACCURACY OF VENTRICULAR CATHETER PLACEMENT ACHIEVED USING INTRAOPERATIVE GUIDANCE TRANSLATES INTO A REDUCTION IN PROXIMAL CATHETER FAILURE. OPTIMAL VENTRICULAR CATHETER PLACEMENT SEEMS TO REDUCE THE LIKELIHOOD OF PROXIMAL SHUNT FAILURE. THE AUTHORS FOUND THAT THE USE OF INTRAOPERATIVE GUIDANCE SIGNIFICANTLY INCREASED THE LIKELIHOOD OF ACCURATE CATHETER PLACEMENT AND ALSO SIGNIFICANTLY DECREASED THE LIKELIHOOD OF PROXIMAL CATHETER FAILURE DURING THE STUDY PERIOD. THE STUDY ALSO SUGGESTS THAT INCREASED INACCURACY OF INTRAOPERATIVE GUIDANCE FOR CATHETERS PLACED WITH A POSTERIOR APPROACH VERSUS FRONTAL. ANECDOTALLY, WE HAVE FOUND THAT STEREOTACTIC NEURONAVIGATION SYSTEMS SEEM TO BE LESS ACCURATE WHEN USED FOR OTHER PURPOSES (E.G., TUMORS) IN THE POSTERIOR PART OF THE HEAD. THESE DATA SUGGEST THAT INTRAOPERATIVE GUIDANCE IS USEFUL FOR IMPROVING ACCURACY OF VENTRICULAR CATHETER PLACEMENT REGARDLESS OF VENTRICLE SIZE. THE ONLY OTHER FACTOR FOUND TO BE PREDICTIVE OF ACCURATE CATHETER PLACEMENT WAS AGE, WITH INCREASING AGE BEING ASSOCIATED WITH AN INCREASED LIKELIHOOD OF INACCURACY. AN EXPLANATION FOR THIS OBSERVATION IS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816996 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other