BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRELLIS 8 80X15

    MDR report key: 4156809 · Received October 9, 2014

    Report

    Report Number
    2183870-2014-00254
    Event Type
    Death
    Date Received
    October 9, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    COVIDIEN-PLYMOUTH
    Product Code
    KRA
    PMA / PMN Number
    K130904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN.  A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 1

    TWO TRELLIS WERE USED TO TREAT THE POPLITEAL VEIN UP TO THE ILIAC VEIN. TWO TRELLIS DEVICES WERE USED BECAUSE THE 15CM CATHETER THAT WAS USED WAS NOT LONG ENOUGH. THE 30CM WAS USED TO COVER THE ENTIRE LESION FOR ADDITIONAL TREATMENT. THREE HOURS POST PROCEDURE IT WAS REPORTED THAT THE PATIENT HAD A CRANIAL BLEED AND EXPIRED. PLEASE REFERENCE MDR 2183870-2014-00253 FOR THE OTHER TRELLIS USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636521 TRELLIS 8 80X15 CATHETER, CONTINUOUS FLUSH KRA COVIDIEN-PLYMOUTH BVT808015 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death