BEUDAMED
    FDA Adverse Event Death Summary report: N

    COIL-THERMO MECHANICAL

    MDR report key: 8287203 · Received January 29, 2019

    Report

    Report Number
    2954740-2019-00538
    Event Type
    Death
    Date Received
    January 29, 2019
    Report Date
    January 7, 2019
    Manufacturer
    SEE H.10
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICAL MANUFACTURER NAME: (B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. PRODUCT COMPLAINT # (B)(4). REPORT NUMBERS 2954740-2019-00536, 2954740-2019-00538, 2954740-2019-00539, 2954740-2019-00540, 2954740-2019-00541 ARE RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿CLINICAL OBSERVATION OF ENDOVASCULAR EMBOLIZATION TREATMENT FOR ACUTE RUPTURED OF INTRACRANIAL ANEURYSMS¿. 1 PATIENT WITH INTRACRANIAL ANEURYSM AND SUBARACHNOID HEMORRHAGE WHO UNDERWENT ENDOVASCULAR TREATMENT (STENT-ASSISTED COIL EMBOLIZATION) WITH TRUFILL DETACHABLE COIL SYSTEM (DCS) HAS DIED OF REBLEEDING AFTER THREE YEARS OBJECTIVE OF THIS STUDY: TO EVALUATE THE CLINICAL EFFICACY OF ENDOVASCULAR EMBOLIZATION FOR ACUTE RUPTURE OF INTRACRANIAL ANEURYSMS WITH TRUFILL DETACHABLE COIL SYSTEM (DCS). FROM JUNE 2005 TO DECEMBER 2010, PERFORMED INTRAVASCULAR EMBOLIZATION TREATMENT IN 96 PATIENTS WITH ACUTE INTRACRANIAL ANEURYSM RUPTURE WERE EMBOLIZED WITH TRUFILL DETACHABLE COIL SYSTEM (DCS). ALL PATIENTS HAD SUBARACHNOID HEMORRHAGE (SAH) AS REVEALED BY SKULL COMPUTED TOMOGRAPHY (CT) EXAMINATION, WITH EIGHT PATIENTS HAVING LOCAL SMALL HEMATOMA FORMATION AND FIVE PATIENTS HAVING HEMORRHAGE INTO THE CEREBRAL VENTRICLES. CLASSIFIED BY HUNT-HESS, THERE WERE 31 CASES OF GRADE I, 35 CASES OF GRADE II, 25 CASES OF GRADE III, 4 CASES OF GRADE IV AND 1 CASE OF GRADE V. THERE WERE 27 ANEURYSMS LOCATED AT THE ANTERIOR COMMUNICATING ARTERY, 40 AT THE POSTERIOR COMMUNICATING ARTERY, 17 AT THE MIDDLE CEREBRAL ARTERY, 5 AT THE ANTERIOR CEREBRAL ARTERY, 12 AT THE INTERNAL CAROTID ARTERY, 3 AT THE BASILAR ARTERY, 2 AT THE POSTERIOR CEREBRAL ARTERY, 1 AT THE UPPER CEREBELLAR ARTERY, AND 1 AT THE POSTERIOR INFERIOR CEREBELLAR ARTERY. THERE WERE 53 ANEURYSMS WITH THE MAXIMUM DIAMETER < 5MM, 51 ANEURYSMS AT 5 TO 10 MM, AND 4 ANEURYSMS > 10MM; THERE WERE 24 WIDE-NECK ANEURYSMS (ANEURYSM NECK > 4 MM OR BODY-NECK RATIO < 1.5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76905 COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death