BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTEGRAFT

    MDR report key: 4722094 · Received April 22, 2015

    Report

    Report Number
    2247686-2015-00002
    Event Type
    Death
    Date Received
    April 22, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 31, 2015
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR FOR ARTEGRAFT COMPLAINT NUMBER (B)(4) WAS SUBMITTED ON (B)(4) 2015. THROMBOSIS AND VASODILATATION FOLLOWED BY PATIENT DEATH. SURGICAL GRAFT IMPLANTED OVER A YEAR AGO BECAME CLOTTED. THE ACTUAL GRAFT WAS NOT EVALUATED BY ARTEGRAFT, INC. NO RESULTS AVAILABLE SINCE NO EVALUATION WAS ABLE TO BE PERFORMED AND ALTHOUGH REQUESTED MULTIPLE TIMES, NO DETAILS WERE PROVIDED BY THE HOSPITAL. THE ISSUE WAS NOT ABLE TO BE CONFIRMED. THE DEVICE WAS NOT RETURNED AND ALTHOUGH REQUESTED, NO LOT INFORMATION WAS PROVIDED. HOWEVER, THROMBOSIS IS A KNOWN INHERENT RISK FOR THE PATIENT POPULATION WITH ARTEGRAFT IMPLANTED. THE COMPLAINT ISSUE WILL BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING.

    Description of Event or Problem · 1

    AS REPORTED FROM THE ARTEGRAFT DISTRIBUTOR (FROM THE P.A.), GENERAL SURGEON IMPLANTED AN AG740 ARTEGRAFT (COLLAGEN VASCULAR GRAFT) IN A MALE PATIENT AT LEAST ONE YEAR AGO. ON AN UNKNOWN DATE, THROMBOSIS OF THE GRAFT OCCURRED. ON (B)(6) 2015, DURING THE THROMBECTOMY PROCEDURE, THE GRAFT WAS THROMBECTOMIZED BY A 7MM AND AN 8MM EMBOLECTOMY BALLOON CATHETER IN INTERVENTIONAL RADIOLOGY. ACCORDING TO THE P.A., THE BALLOON DID NOT TOUCH THE GRAFT WALL. THE GRAFT ALLEGEDLY DILATED TO 10MM UNIFORMLY ALONG THE ENTIRE LENGTH. IT IS UNCLEAR AT WHAT TIME THE DILATION OCCURRED AND WHAT CAUSED IT. THE PATIENT DIED DURING THE PROCEDURE. THE P.A. STATED THAT THERE IS NO CLEAR WAY TO INDICATE THAT THE COMPLICATIONS THAT RESULTED FROM THE PROCEDURE WERE DIRECTLY RELATED TO THE GRAFT THAT WAS PLACED. ARTEGRAFT CONTACTED THE DISTRIBUTOR, P.A., AND THE HOSPITAL FOR ADDITIONAL INFORMATION REGARDING THE LOT NUMBER, PATIENT INFORMATION, AND A DETAILED DESCRIPTION OF THE DATES AND TIMELINE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER MULTIPLE ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266754 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC. AG740

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L