BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 6952661 · Received October 16, 2017

    Report

    Report Number
    2134265-2017-10008
    Event Type
    Death
    Date Received
    October 16, 2017
    Report Date
    September 25, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P980033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: NADER ABDEL-RAHMANA. ¿METALLIC STENTS FOR AIRWAY COMPLICATIONS AFTER LUNG TRANSPLANTATION¿ PUBLICATION 15 SEPTEMBER 2013: PAGES 855-858. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE CAUSE OF THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2017-10009. IT WAS REPORTED VIA A LITERATURE ARTICLE THAT PATIENT DEATHS OCCURRED POST STENT IMPLANT. THE PATIENT PROCEDURES OCCURRED BETWEEN JANUARY 1997 AND MARCH 2013. THE INDICATIONS FOR LUNG TRANSPLANT (LTX) IN THESE PATIENTS WERE: CYSTIC FIBROSIS, EMPHYSEMA, PULMONARY FIBROSIS, PULMONARY HYPERTENSION. ALL PATIENTS WHO REQUIRED THE SELF-EXPANDING METALLIC STENTING (SEMS) PLACEMENT PRESENTED WITH SIGNS AND SYMPTOMS OF AIRWAY OBSTRUCTION INCLUDING SHORTNESS OF BREATH, COUGH, EFFORT DYSPNOEA AND WHEEZING. NO IMMEDIATE SIGNIFICANT COMPLICATIONS WERE ASSOCIATED WITH THE SELF-EXPANDING METALLIC STENTING INSERTION PROCEDURE. DURING A MEDIAN FOLLOW-UP PERIOD OF 54 (RANGE 1¿132) MONTHS, 18 (38%) PATIENTS IN WHOM SEMS HAD BEEN PLACED DIED. THE MEDIAN SURVIVAL IN DAYS FROM LTX WAS 1727 (RANGE 98¿3401) DAYS. THE MAJOR CAUSE OF DEATH WAS INFECTION, FOLLOWED BY MALIGNANCY AND GRAFT REJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730684 WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY UNK679

    Patients

    Seq Age Sex Outcome Treatment
    1 Death