BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUSION 8MM-80CM SUPP PERIPHERAL GRAFT

    MDR report key: 3812341 · Received May 5, 2014

    Report

    Report Number
    2242352-2014-00508
    Event Type
    Death
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    PMA / PMN Number
    K131778
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A POST-OPERATIVE INFECTION WITH A PT HAVING SURGERY WITH THE FUSION 8MM-8CM SUPP PERIPHERAL GRAFT. IT WAS REPORTED THAT THERE WAS EXCESSIVE BLEEDING FROM THE INFECTED AREA AFTER THE SURGERY. DATE OF INITIAL SURGERY WAS (B)(6) 2014 INFECTING AGENT: STAPHYLOCOCCUS AUREUS. PRIMARY DISEASE: ARTERIOSCLEROSIS OBLITERANS CAUSED BY LEFT SUPERFICIAL FEMORAL ARTERY STENOSIS FONTAINE "IS NOT EQUAL TO U" ON (B)(6) 2014, THE PATIENT WAS HOSPITALIZED AND ANTIBIOTICS WERE ADMINISTERED. ON (B)(6) 2014, THE VASCULAR GRAFT WAS REMOVED, SVG PATCH WAS CREATED. ON (B)(6) 2014, EXCESSIVE BLEEDING WAS NOTED FROM THE SURGICAL WOUND SITE IN THE GROIN. THE SURGEON INCISED THE SURGICAL WOUND AGAIN AND STOPPED BLEEDING. ON (B)(6) 2014, REBLEEDING OCCURRED FROM THE GROIN. ANOTHER SURGERY WAS DONE TO CONDUCT BYPASS SURGERY OF EXTERNAL ILIAC ARTERY, DEEP FEMORAL ARTERY AND SUPERFICIAL FEMORAL ARTERY BY SVG Y-GRAFT. ON (B)(6) 2014 REBLEEDING OCCURRED FROM THE SVG, WHICH WAS NOT THE ANASTOMOSIS SITE. THE SURGEON THOUGHT THAT THE SVG WAS INFECTED. ON (B)(6) 2014, REBLEEDING OCCURRED AND ASTRICTION WAS CONDUCTED. THE PATIENT EXPIRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267915 FUSION 8MM-80CM SUPP PERIPHERAL GRAFT VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC M002015030880 25085577

    Patients

    Seq Age Sex Outcome Treatment
    1 Death