BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTEGRAFT

    MDR report key: 5682638 · Received May 26, 2016

    Report

    Report Number
    2247686-2016-00006
    Event Type
    Death
    Date Received
    May 26, 2016
    Date of Event
    July 28, 2015
    Report Date
    April 28, 2016
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE MANUFACTURER BATCH NUMBER AND DETAILS RELATED TO THE EVENT; HOWEVER, TO DATE NO ADDITIONAL INFORMATION WAS PROVIDED. NO COMPLAINT TREND WAS IDENTIFIED RELATED TO PATIENT DEATH. THE COMPLAINT ISSUE WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    MEDWATCH REPORT MW5061342 WAS RECEIVED. A FAMILY MEMBER OF THE PATIENT REPORTED THAT THE PATIENT HAD EXPIRED. THE REPORTER STATED THAT THE PATIENT WAS A DIALYSIS PATIENT FOR 11 YEARS. "NEVER HAVING ANY SIGNIFICANT PROBLEM WITH HIS ONE AND ONLY ACCESS SITE." HIS ACCESS SITE CLOTTED OFF DURING TREATMENT. MULTIPLE PROCEDURES (BALLOONING, STENT, CHEST WALL PORT, REPEAT ANGIOPLASTY) WERE PERFORMED AS A RESULT OF NUMEROUS CLOT ISSUES, THE PATIENT'S VASCULAR SURGEON THEN IMPLANTED A "BOVINE GRAFT" (ARTEGRAFT, COLLAGEN VASCULAR GRAFT). AFTER IMPLANT OF THE ARTEGRAFT, INITIAL BLOOD FLOW WAS REPORTED AS "GOOD". AFTER AN UNKNOWN TIME PERIOD, THE PATIENT WENT FOR DIALYSIS TREATMENT AND THE GRAFT "HAD CLOTTED OFF". A DECLOT PROCEDURE WAS SCHEDULED THE FOLLOWING WEEK. AFTER THE PROCEDURE, ON (B)(6) 2015 APPROX. 2PM THE PATIENT REPORTED DIFFICULTY BREATHING. THE PATIENT HAD A CHEST X-RAY AND BREATHING TREATMENT AND WAS GIVEN A BENADRYL. PATIENT WAS DISCHARGED FROM THE HOSPITAL AND APPROX. 2 HOURS LATER THE PATIENT EXPIRED. THE REPORTER STATES THAT THE PATIENT "WAS IN GOOD HEALTH ALTHOUGH HE WAS A DIALYSIS PATIENT. HE WAS ALERT ACTIVE AND VERY INVOLVED WITH LIFE." THE REPORTER FURTHER STATES, "MY CONCERNS ARE THAT EITHER THE PROBLEM STEMMED FROM THE BOVINE GRAFT OR THE STENTS PLACED IN HIS ARM. HE ALSO HAD A CORONARY STENT PLACED IN 2013 AND THERE HAVE BEEN REPORTS OF STENTS FRACTURING AND CAUSING ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336670 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death AMIODARONE