BEUDAMED
    FDA Adverse Event Death Summary report: N

    LVIS JR. INTRALUMINAL SUPPORT

    MDR report key: 5094845 · Received September 22, 2015

    Report

    Report Number
    2032493-2015-00145
    Event Type
    Death
    Date Received
    September 22, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 26, 2015
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE LVIS JR. DEVICE IS INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF INTRACRANIAL NEUROVASCULAR DISEASES. USE OF THE LVIS JR. DEVICE IS CONTRAINDICATED UNDER THESE CIRCUMSTANCES: PATIENTS IN WHOM ANTICOAGULANT, ANTIPLATELET THERAPY OR THROMBOLYTIC DRUGS ARE CONTRAINDICATED. PATIENTS WITH KNOWN HYPERSENSITIVITY TO NICKEL-TITANIUM. PATIENTS WITH ANATOMY THAT DOES NOT PERMIT PASSAGE OR DEPLOYMENT. PER THE INSTRUCTIONS FOR USE, POSSIBLE COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: BLEEDING OR HEMORRHAGE INCLUDING INTRACEREBRAL, RETROPERITONEAL OR OTHER LOCATIONS. COMPLICATIONS OF ARTERIAL PUNCTURE INCLUDING PAIN, LOCAL BLEEDING (HEMATOMA) OR INJURY TO THE ARTERY OR ADJACENT NERVES. DEVICE MIGRATION. DISTAL EMBOLIZATION. HEADACHE. INCOMPLETE ANEURYSM OCCLUSION. NEUROLOGIC DEFICITS INCLUDING STROKE AND/OR DEATH. PERFORATION OR DISSECTION OF THE VESSEL(S). PSEUDOANEURYSM FORMATION. RUPTURE OR PERFORATION OF ANEURYSM. TRANSIENT ISCHEMIC ATTACK (TIA) OR ISCHEMIC STROKE. VASOSPASM. VESSEL OCCLUSION. VESSEL STENOSIS OR THROMBOSIS. THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT RETURNED AS IT REMAINS WITHIN THE PATIENT. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED; HOWEVER, THERE WAS NO REPORT OR INFORMATION INDICATING THAT A MALFUNCTION OCCURRED WITH THE LVIS DEVICE. THE OP REPORT INDICATED THE FOLLOWING: "THE LVIS JR. DEVICE WAS USED AS PART OF THE ANEURYSM COILING PROCEDURE, BUT THE DEVICE ITSELF WAS NOT RESPONSIBLE FOR THE ANEURYSM RUPTURE AND DEATH; THIS WAS DUE TO PERFORATION OF THE ANEURYSM BY THE COILS USED FOR ANEURYSM TREATMENT. HOWEVER, THE LVIS JR. DEVICE THROMBOSED, WHICH MAY HAVE CONTRIBUTED TO THE EVENTS OF THIS CASE, AS THE OPERATOR WAS PLACING THE COILS IN A MORE RAPID FASHION THAN USUAL IN ORDER TO OCCLUDE THE ANEURYSM QUICKLY SO THAT HE COULD ADDRESS THE ISSUE OF THE THROMBOSED LVIS JR. DEVICE (TREATMENT OF THE THROMBOSIS WOULD REQUIRE USE OF THROMBOLYTIC MEDICATIONS WHICH COULD CAUSE HEMORRHAGE FROM THE ANEURYSM IF IT WAS NOT ADEQUATELY PROTECTED PRIOR TO THROMBOLYTIC ADMINISTRATION)." THE COILS USED IN THIS CASE WERE NOT MVI, INC. MANUFACTURED COILS. THE INFORMATION FOR THESE COILS (MFG./MODEL/LOT) WAS NOT PROVIDED. REFERENCE MVI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TREATMENT OF A LEFT MCA ANEURYSM, MEASURING UP TO 14MM WITH NECK INTEGRATING WITH THE LEFT MCA TRIFURCATION. THE LVIS JR. STENT WAS SUCCESSFULLY PLACED IN THE MCA M1 TO M2, CROSSING THE ANEURYSM NECK. THE ANEURYSM WAS THEN COILED. REPRO WAS ADMINISTERED TO PREVENT THROMBOSIS IN THE STENT. HOWEVER, AT THIS POINT AN ANGIOGRAM REVEALED CLOTS IN THE STENTED LEFT MCA M1 AND M2. TO ALLOW FURTHER ANTIPLATELET AND THROMBOLYSIS THERAPY, THE ANEURYSM WAS THEN QUICKLY PACKED WITH AN ADDITIONAL COIL. THERE WAS A PERFORATION OF THE ANEURYSM DURING THIS COIL PLACEMENT, THE BLEED WAS STOPPED BY ADDITIONAL COILING IN 3 TO 4 MINUTES. AFTER ANGIOGRAM SHOWED COMPLETE OCCLUSION OF THE ANEURYSM ACHIEVED WITHOUT ACTIVE BLEED. ADDITIONAL 8 MG REOPRO AND 2 MG TPA WERE GIVEN IA IN LEFT M1, THIS RESOLVED THE CLOTS, RE-OPENED ALL THE MAJOR LEFT MCA BRANCHES. THE PATIENT'S VITALS WERE STABLE AT THE END OF THE PROCEDURE. PATIENT WAS THEN SENT FOR STAT CT, WHICH SHOWED A LARGE INTRAPARENCHYMAL HEMATOMA IN LEFT TEMPORAL / PARIETAL WITH MIDDLE LINE SHIFTING AND UNCAL HERNIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626502 LVIS JR. INTRALUMINAL SUPPORT INTRALUMINAL STENT NJE MICROVENTION, INC. LVIS JR 2.5X23 (HDE) 14100226M

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death