BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24MM HEMA PLAT ANGLED 4 BR WDV AORTIC GR

    MDR report key: 3010335 · Received March 14, 2013

    Report

    Report Number
    2242352-2013-00272
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    PMA / PMN Number
    K012952
    Removal / Correction Number
    NA
    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 EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOPS, 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 NONCONFORMANCE RECORDED IN THE LOT HISTORY. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THE BATCH IN QUESTION. ALL GRAFTS MANUFACTURED WITHIN THIS BATCH PASSED NON-DESTRUCTIVE PERMEABILITY TESTING, PER PRODUCT SPECIFICATION. IN ADDITION, A REPRESENTATIVE SAMPLE UNDERWENT WATER POROSITY TESTING AND WAS FOUND TO BE WELL WITHIN PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT A 24MM HEMASHIELD PLATINUM ANGLED AORTIC GRAFT WAS USED FOR A REPAIR OF AN AORTIC ARCH ANEURYSM. THE PATIENT WAS PLACED ON AN ARTIFICIAL HEART-LUNG MACHINE TO CONDUCT EXTRACORPOREAL CIRCULATION AND REPLACE AN AORTA AND EACH OF ITS BRANCHES. WHEN THEY RESTARTED THE CIRCULATION, BLOOD LEAKAGE WAS FOUND AT THE BIFURCATED PART OF LEFT COMMON CAROTID ARTERY. THE HOSPITAL REPORTED THAT THE PATIENT LOST APPROXIMATELY 100 ML OF BLOOD AND A TRANSFUSION WAS NOT REQUIRED. THE PHYSICIAN ATTEMPTED TO STOP THE BLEEDING BY SUTURING THE SITE, BUT THE SUTURE WAS NOT TIGHT ENOUGH DUE TO THE LOCATION. A HEMOSTATIC AGENT WAS USED TO STOP THE BLEEDING. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCT IN QUESTION AS THE PRODUCT HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108545 24MM HEMA PLAT ANGLED 4 BR WDV AORTIC GR VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC VS02175724AP0 12306864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other