BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PLASMABLADE DEVICE

    MDR report key: 8320283 · Received February 8, 2019

    Report

    Report Number
    1226420-2019-00015
    Event Type
    Death
    Date Received
    February 8, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 8, 2019
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ARTICLE: SKELETONIZED INTERNAL THORACIC ARTERY HARVESTING: A LOW THERMAL DAMAGE ELECTROSURGICAL DEVICE PROVIDES IMPROVED ENDOTHELIAL LAYER AND TENDENCY TO BETTER INTEGRITY OF THE VESSEL WALL COMPARED TO CONVENTIONAL ELECTROSURGERY BACKGROUND: ELECTROSURGERY IS FUNDAMENTAL TO THE PRECISE, FAST AND BLOODLESS PREPARATION OF INTERNAL THORACIC ARTERY GRAFTS IN CARDIAC SURGERY. THE PEAK PLASMABLADE IS A MONOPOLAR ELECTROSURGICAL DEVICE THAT USES PULSED RADIOFREQUENCY ENERGY TO GENERATE A PLASMA-MEDIATED DISCHARGE ALONG AN INSULATED ELECTRODE, CREATING A CUTTING EDGE WHILE THE BLADE STAYS NEAR BODY TEMPERATURE. THE AIM OF THIS STUDY IS TO COMPARE THE HISTOLOGICAL SAMPLES, CARDIAC COMPUTED-TOMOGRAPHY OF GRAFT PATENCY, AND CLINICAL OUTCOMES OF PATIENTS AFTER OFF-PUMP CORONARY ARTERY BYPASS GRAFTING WITH PREPARATION OF THE INTERNAL THORACIC ARTERIES BY A CONVENTIONAL ELECTROSURGICAL DEVICE AND THE PLASMABLADE. METHODS: IN TWENTY SUBJECTS ONE INTERNAL THORACIC ARTERY WAS PREPARED WITH PLASMABLADE AND THE OTHER ARTERY WITH A CONVENTIONAL ELEC TROSURGICAL DEVICE. HISTOLOGICAL SAMPLES WERE EVALUATED FOR THREE FACTORS FOR POTENTIAL GRAFT FAILURE: ENDOTHELIAL DAMAGE, INTEGRITY OF THE VESSEL WALL AND ADVENTITIAL HEMORRHAGE. FIVE SAMPLES PER ARTERY WERE EVALUATED BY A NOVEL SCORING METHOD BASED ON THE EXPOSED CIRCUMFERENCE OF THE HISTOLOGICAL SAMPLE (¿0¿: 0%, ¿1¿: 1¿25%, ¿2¿: 26¿50%, ¿3¿: 51¿75%, ¿4¿: =76% OF THE CIRCUMFERENCE). THE WILCOXON SIGNED RANKS TEST FOR MEAN SCORES WITHIN SUBJECTS WAS PERFORMED. SIX-MONTH-FOLLOW UP BY CARDIAC COMPUTED TOMOGRAPHY FOR EVALUATION OF GRAFT PATENCY WAS COMPLETED IN 16 PATIENTS. ADVERSE EVENTS REPORTED: SIXTEEN OF TWENTY POSSIBLE FOLLOW-UP CTS WERE PERFORMED. ONE PATIENT SUFFERED FROM POSTOPERATIVE RENAL FAILURE AND COULD NOT UNDERGO THE INVESTIGATION. ONE PATIENT DIED AT THE FIRST POSTOPERATIVE DAY IN THE INTENSIVE CARE UNIT WITH PROGRESSIVE MULTIORGAN FAILURE AS A RESULT OF A FULMINANT VASOPLEGIC SHOCK AND EMERGENT INSTALLATION OF EXTRACORPORAL CIRCULATORY MEMBRANE SUPPORT MOST LIKELY BECAUSE OF AN ANAPHYLACTIC REACTION. THERE WERE NO PATIENT IDENTIFIERS WITHIN THE ARTICLE; THEREFORE, THE PATIENTS WILL BE REPORTED AS A WHOLE AND NO OTHER RECORDS WILL BE CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114767 UNKNOWN PLASMABLADE DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK PEAK DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death