BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLEEVE 14F

    MDR report key: 10596563 · Received September 28, 2020

    Report

    Report Number
    2134265-2020-13233
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    August 3, 2018
    Report Date
    September 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY WITH A PATIENT IDENTIFIER (B)(6). (B)(6) IS AN INVESTIGATOR-SPONSORED RESEARCH (ISR) CLINICAL STUDY INVOLVING THE ACCURATE NEO AORTIC BIOPROSTHESIS AND THE ACCURATE TF TRANSFEMORAL DELIVERY SYSTEM. BOSTON SCIENTIFIC (BSC) RECEIVED DATA IN AN ANONYMIZED FORMAT. THEREFORE, FOR MAINTAINING PATIENT ANONYMITY, ONLY LIMITED INFORMATION WAS DISCLOSED TO BSC. BSC IS UNABLE TO ACQUIRE ANY FURTHER INFORMATION. PROCEDURE SUMMARY: THE PATIENT UNDERWENT THE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. A 14F ISLEEVE INTRODUCER SHEATH WAS SELECTED FOR USE DURING THE PROCEDURE AND AN ACURATE NEO VALVE WAS IMPLANTED. 2 DAYS POST PROCEDURE, A VASCULAR DISSECTION OF THE PUNCTURE SITE WITH CALCIFICATION DETACHMENT WAS OBSERVED. THE DISSECTION WAS TREATED WITH CROSS-OVER DILATATION AND IMPLANTATION OF A 8X60MM NON-BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060281 ISLEEVE 14F INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC CORPORATION 10445

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention