BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO NYLON HELIX

    MDR report key: 10350489 · Received July 31, 2020

    Report

    Report Number
    2029214-2020-00757
    Event Type
    Death
    Date Received
    July 31, 2020
    Date of Event
    April 23, 2020
    Report Date
    July 31, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    PMA / PMN Number
    K090046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SILVERBERG D, BAR-DAYAN A, RIMON U, RASKIN D, FEFER P, HALAK M. THE JAILED COILING TECHNIQUE FOR THE TREATMENT OF PENETRATING ULCERS AND SACCULAR ANEURYSMS OF THE AORTIC ARCH. VASCULAR AND ENDOVASCULAR SURGERY. 2020;54(5):423-429. DOI:10.1177/1538574420921282. THE CONCERTO COIL WILL NOT BE RETURNED AS IMPLANTED IN THE PATIENT. BASE ON THE REPORTED INFORMATION THERE WERE NOT ANY DEVICE ISSUE DURING THE USE. THE EVENTS OCCURRED IN POST PROCEDURE AND CAUSE WAS UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW. THERE WAS 1 PERIOPERATIVE MORTALITY. THIS PATIENT, WHO HAD SEVERE CARDIAC DISEASE, PRESENTED WITH A SYMPTOMATIC, ENLARGING 7-CM SA. THE PATIENT UNDERWENT AN AXILLARY¿AXILLARY BYPASS FOLLOWED BY TEVAR AND COILING OF HIS SA. THE SURGERY WAS UNEVENTFUL, HOWEVER HE EXPIRED ON POSTOPERATIVE DAY 2 DUE TO AN EXTENSIVE MYOCARDIAL INFARCTION. TECHNICAL SUCCESS WAS ACHIEVED IN ALL PATIENTS, RESULTING IN OBLITERATION OF THE ANEURYSM LUMEN. NO PATIENT SUFFERED FROM A PERIOPER ATIVE CEREBROVASCULAR EVENT, SPINAL CORD ISCHEMIA OR INADVERTENT COVERAGE OF A SUPRA-AORTIC VESSEL. IN ALL CASES, THE COILS (CONCERTO COILS) WERE DELIVERED ACCURATELY, WITH NO EVENTS OF COIL MIGRATION INTO THE AORTA. 9 PATIENTS UNDERWENT TREATMENT FOR PENETRATING AORTIC ULCERS (PAUS) AND SACCULAR ANEURYSMS (SAS) OF THE ARCH. MEAN AGE WAS 70 YEARS (RANGE 60-79) AND ALL PATIENTS WERE MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815328 CONCERTO NYLON HELIX DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death