BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIA-21 MICROCATHETER-US VIA-21-154-01FOR US

    MDR report key: 9264704 · Received October 31, 2019

    Report

    Report Number
    2032493-2019-00254
    Event Type
    Death
    Date Received
    October 31, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 1, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    DQY
    UDI-DI
    00851566003918
    PMA / PMN Number
    K150894
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO THE MANUFACTURER: THE DATE OF THE PATIENT'S DEATH IS (B)(6) 2019. THE DOCUMENTED CAUSE OF DEATH ON THE DEATH CERTIFICATE IS CARDIOPULMONARY ARREST SECONDARY TO ANEURYSMAL SUBARACHNOID HEMORRHAGE DUE TO CEREBRAL ANEURYSM.

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCE ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. HOWEVER, THE REPORTED CLINICAL INFORMATION INDICATES THERE WAS NO MALFUNCTION OR ISSUE WITH THE MICROVENTION DEVICE. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES ANEURYSM RUPTURE, VESSEL PERFORATION, HEMORRHAGE, VASCULAR THROMBOSIS, AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A PATIENT WITH RUPTURED ANEURYSMS AND A DUAL HEMORRHAGIC STROKE INVOLVING THE DISTAL ANTERIOR CEREBRAL ARTERY (ACA) AND THE POSTERIOR COMMUNICATING ARTERY (PCOM) ON THE SAME SIDE. AFTER SUCCESSFUL IMPLANTATION OF TWO WEB DEVICES AND STASIS OF BOTH ANEURYSMS, THE FINAL ANGIOGRAPHY RUN DEMONSTRATED CLOT FORMING ON THE INTERMEDIATE CATHETER (NON-MV DEVICE) AND THE VIA MICROCATHETER IN THE A2 ARTERY. THE VIA WAS REMOVED, AND ASPIRATION AND MECHANICAL THROMBECTOMY WERE PERFORMED. EXTRAVASATION WAS THEN NOTICED IN THE INTERNAL CAROTID ARTERY AND PCOM ORIGIN. THE WEB IN THE PCOM ANEURYSM APPEARED TO BE INTACT WITH NO VISIBLE DEFORMATIONS. A BALLOON WAS INFLATED AT THE SITE OF EXTRAVASATION, WHICH REDUCED THE BLEEDING. THE PATIENT WAS ADMITTED TO THE ICU. IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY ONE WEEK POST-PROCEDURE; HOWEVER, THE CAUSE AND EXACT DATE OF THE PATIENT'S DEATH ARE UNKNOWN. THE PHYSICIAN DID NOT CONSIDER THERE TO HAVE BEEN A MALFUNCTION OR ISSUE WITH A MICROVENTION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057306 VIA-21 MICROCATHETER-US VIA-21-154-01FOR US MICROCATHETER DQY SEQUENT MEDICAL, INC FGA21154-01 19051304 00851566003918

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R