BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM

    MDR report key: 7011280 · Received November 8, 2017

    Report

    Report Number
    2021898-2017-00564
    Event Type
    Death
    Date Received
    November 8, 2017
    Report Date
    December 19, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE. PLEASE NOTE THAT THIS WEIGHT IS THE AVERAGE WEIGHT OF THE PATIENTS REPORTED IN THE ARTICLE. THIS EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    YAMUME TSHOMBA, MARCO LEOPARDI, DANIELE MASCIA, ANDREA KAHLBERG, ANDREA CAROZZO, SILVIO MAGRIN, GERMANO MELISSANO, ROBERTO CHIESA. AUTOMATED PRESSURE-CONTROLLED CEREBROSPINAL FLUID DRAINAGE DURING OPEN THORACOABDOMINAL AORTIC ANEURYSM REPAIR. JOURNAL OF VASCULAR SURGERY 66 (2017). DOI: 10.1016/J.JVS.2016.11.057 OBJECTIVE: PERIOPERATIVE CEREBROSPINAL FLUID (CSF) DRAINAGE IS A WELL-ESTABLISHED TECHNIQUE FOR SPINAL CORD PROTECTION DURING THORACOABDOMINAL AORTIC ANEURYSM (TAAA) OPEN REPAIR AND IS USUALLY PERFORMED USING DRIPPING CHAMBER-BASED SYSTEMS. A NEW AUTOMATED DEVICE FOR CONTROLLED AND CONTINUOUS CSF DRAINAGE, DESIGNED TO MAINTAIN CSF PRESSURE AROUND THE DESIRED SET VALUES, THUS AVOIDING UNNECESSARY DRAINAGE, IS CURRENTLY AVAILABLE. THE AIM OF OUR STUDY WAS TO DETERMINE WHETHER THE USE OF THE NEW LIQUOGUARD AUTOMATED DEVICE (MÖLLER MEDICAL (B)(4)) DURING TAAA OPEN REPAIR WAS SAFE AND EFFECTIVE IN MAINTAINING THE DESIRED CSF PRESSURE VALUES AND WHETHER THE INCIDENCE OF COMPLICATIONS WAS REDUCED COMPARED WITH A STANDARD CATHETER CONNECTED TO A DRIPPING CHAMBER. METHODS: DATA OF PATIENTS WHO UNDERWENT SURGICAL TAAA OPEN REPAIR USING PERIOPERATIVE CSF DRAINAGE AT OUR INSTITUTION BETWEEN OCTOBER 2012 AND OCTOBER 2014 WERE RECORDED. THE DIFFERENCE IN CSF PRESSURE VALUES BETWEEN PATIENTS WHO UNDERWENT CSF DRAINAGE WITH A CONVENTIONAL DRIPPING CHAMBER-BASED SYSTEM (MANUAL GROUP) AND PATIENTS WHO UNDERWENT CSF DRAINAGE WITH THE LIQUOGUARD (AUTOMATED GROUP) WAS MEASURED AT THE BEGINNING OF THE INTERVENTION (T1), 15 MINUTES AFTER AORTIC CROSS-CLAMPING (T2), JUST BEFORE UNCLAMPING (T3), AT THE END OF SURGERY (T4), AND 4 HOURS AFTER THE END OF SURGERY (T5). THE CHOICE OF THE DRAINING SYSTEMS WAS RANDOMLY ALTERNATED WITH ONE-TO-ONE RATE UNTIL THE LAST SIX PATIENTS CONSECUTIVELY TREATED WITH LIQUOGUARD WERE ENROLLED. PRIMARY OUTCOMES WERE OCCURRENCE OF SPINAL CORD ISCHEMIA, INTRACRANIAL HEMORRHAGE, POSTDURAL PUNCTURE HEADACHE, AND IN-HOSPITAL MORTALITY. RESULTS: THE STUDY INCLUDED 152 PATIENTS WHO UNDERWENT OPEN SURGICAL TAAA REPAIR DURING THE STUDY PERIOD: 73 PATIENTS UNDERWENT CSF DRAINAGE WITH THE TRADITIONAL SYSTEM AND 79 WITH LIQUOGUARD. THE CSF PRESSURE VALUES AT T1 AND T5 WERE NOT CONSIDERABLY DIFFERENT IN THE TWO GROUPS. BY REPEATED-MEASURES ANALYSIS OF VARIANCE, A SIGNIFICANT UPWARD TREND OF PERIOPERATIVE CSF PRESSURE WAS OBSERVED IN THE AUTOMATED GROUP AT T2, T3, AND T4 (GROUP TIME INTERACTION ¼ F3,66; P <(><<)> .001). NO DIFFERENCE WAS REPORTED IN THE OCCURRENCE OF SPINAL CORD ISCHEMIA, INTRACRANIAL HEMORRHAGE, OR MORTALITY. THE LIQUOGUARD GROUP REPORTED SIGNIFICANTLY REDUCED POSTDURAL PUNCTURE HEADACHE (3.3% VS 16.9%; P ¼ . 01). CONCLUSIONS: PERIOPERATIVE USE OF LIQUOGUARD DURING TAAA OPEN REPAIR WAS SAFE AND EFFECTIVE. DESPITE SLIGHTLY HIGHER INTRAOPERATIVE CSF PRESSURES, THE RATE OF SPINAL CORD ISCHEMIA DID NOT INCREASE IN THE LIQUOGUARD GROUP, AND POSTDURAL PUNCTURE HEADACHE SIGNIFICANTLY DECREASED. REPORTED EVENTS: 6 PATIENTS DIED IN THE HOSPITAL WITHIN 30 DAYS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ADVERSE EVENTS MENTIONED IN THE ARTICLE WERE NOT DIRECTLY RELATED TO THE PRODUCT. THE ADVERSE EVENTS WERE ALL POSSIBLE COMPLICATIONS RELATED TO THE TYPE OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788901 UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY UNKNOWN-E UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death