BEUDAMED
    FDA Adverse Event Death Summary report: N

    LVIS JR 2.5X23 (HDE)

    MDR report key: 5756905 · Received June 28, 2016

    Report

    Report Number
    2032493-2016-00150
    Event Type
    Death
    Date Received
    June 28, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NJE
    UDI-DI
    00812636020143
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE COMPLAINT CANNOT BE CONFIRMED. THE DEVICE COULD NOT BE EVALUATED AS IT REMAINS WITHIN THE PATIENT. NO DEVICE MALFUNCTION WAS REPORTED WITH THE MVI, INC. DEVICES USED, HOWEVER AN ADVERSE EVENT OCCURED FOLLOWING THE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTED TO BE A (B)(6) FEMALE PRESENTING WITH ANTRA COMMUNICATING ARTERIES, 7X5XX4MM ANEURYSM. THE PATIENT WAS ELECTIVELY ADMITTED FOR TREATMENT OF THE WIDE NECK ANEURYSM. THE PATIENT WAS PREPPED, BILATERAL GROINS WERE PREPPED IN USUAL FASHION. ACCESS WAS MADE USING ULTRASOUND GUIDANCE. PREVIOUSLY SELECTED COILING VIEWS WERE SELECTED. AN ATTEMPT TO CROSS THE IPSILATERAL A2 SEGMENT WITH A BALLOON CATHETER AND MICROCATHETER WAS UNSUCCESSFUL. ACCESS THE CONTRALATERAL A2 AND DEPLOYED A LVIS STENT. A MICROCATHETER WAS ADVANCED INTO THE ANEURYSM AND THE MICROWIRE WAS REMOVED. ANGIOGRAPHIC RUNS WERE USED TO VERIFY THE POSITION OF THE SYSTEM. AN ATTEMPTED WAS MADE TO RE-ACCESS THE ANEURYSM FROM THE RIGHT A2 SEGMENT, BUT THE MICROWIRE PUNCTURED THE ANEURYSMAL DOME LEADING TO EXCELLENT POSITION. ACT WAS NORMALIZED WITH PROTAMINE. BLOOD PRESSURE WAS CONTROLLED TO LESS THAN 140. AFTER REPEATED ATTEMPTS, ACCESS WAS MADE TO THE ANEURYSM FROM THE RIGHT A2, A COIL WAS DEPLOYED. ACCESS WAS DIFFICULT THROUGH STENT TYNES SO THE ACCESS WAS CHANGED TO THE LEFT INTERNAL CAROTID ARTERY. THE ANTERIOR LOBE OF THE ANEURYSM WAS COILED. FOLLOW-UP VIEWS REVEALED NO ACTIVE EXTRAVASATION, BUT THE PHYSIOLOGIC MONITORING REMAIN DIARRHEA. CEREBRAL INFLOW PLANE SLOW. ACCESS DEVICES WERE REMOVED AND PUNCTURE SITE WAS COVERED. THE PATIENT WAS TRANSPORTED TO THE RECOVERY AREA IN STABLE CONDITION. NO IMMEDIATE COMPLICATIONS WERE ENCOUNTERED. IMAGING REVEALED THE LVIS STENT IN GOOD POSITION. ADDITIONAL INFORMATION RECEIVED 6/7/2016: THE PATIENT HAS BEEN DECLARED BRAIN DEAD. THE FAMILY IS IN THE PROCESS OF WITHDRAWING SUPPORT. ADDITIONAL INFORMATION RECEIVED 6/10/2016: LIFE SUPPORT WAS WITHDRAWN. DATE OF DEATH IS, (B)(6) 2016; 15:05. ADDITIONAL DEVICES USED: MICROPUNCTURE SET, 0.035" J GUIDE WIRE, 5FR PINNACLE SHEATH, 0.035" TERUMO GUIDE WIRE, SIMMONS 2 CATHETER, COOK SHUTTLE SHEATH, 072 NAVIEN, ECHELON 10 MICROCATHETER, HEADWAY 17 MICROCATHETER, SYNCHRO 2 010 MICROWIRE, SYNCHRO 2 014 MICROWIRE, STRYKER TARGET, PENUMBRA SMARTCOIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410220 LVIS JR 2.5X23 (HDE) LVIS JR. NJE MICROVENTION, INC. 172020-LVISJ-C-HDE 16030935 00812636020143

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| O