BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 1665592 · Received April 20, 2010

    Report

    Report Number
    2242352-2010-01312
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 6, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SHIP HISTORY WAS PERFORMED AND A POSSIBLE BATCH WAS IDENTIFIED BASED ON SHIP TO AND EXPIRATION DATE INFO. DHR REVIEW PENDING. EXPLANT DATE: AND DEVICE CODE: THE GRAFT WAS EXPLANTED; HOWEVER, THE EXACT DATE IS UNK. (B) (4), MANUFACTURER REPORT NUMBER 2242351-2010-1311, FOR THE OTHER MAQUET DEVICE USED IN THIS PROCEDURE.).

    Description of Event or Problem · 1

    ON APRIL 6, 2010, WE BECAME AWARE OF A COMPLAINT FROM THE (B) (6) HOSPITAL AND CLINIC PERTAINING TO THE DEATH OF A MALE FARMER AFTER AN AORTIC DISSECTION. THE MAQUET CARDIOVASCULAR REGULATORY DEPARTMENT WAS NOTIFIED BY THE LOCAL FDA OFFICE OF THE INCIDENT. DURING EXPLANT MOLD WAS FOUND BY THE GRAFT. THE MOLD WAS DETERMINED TO BE ASPERGILLUS. THE MAQUET PRODUCTS WERE IDENTIFIED AS HEMASHIELD (B) (4), 8MM X 15 CM AND HEMASHIELD (B) (4), SINGLE BRANCH 28 X 50 X 10. A CRYOLIFE PRODUCT WAS ALSO MENTIONED AS BEING USED IN THE PROCEDURE DURING THE CALL BUT WAS UNSURE OF THE RELATIONSHIP. IF ANY, TO THE COMPLAINT. THIS INFO WAS LATER SUBMITTED BY THE (B) (6) HOSPITAL AND CLINIC ON (B) (6), 2010 VIA A VOLUNTARY 3500A REPORT. THE USER FACILITY REPORTED THAT IT IS POSSIBLE (ALTHOUGH HAS NOT BEEN DETERMINED) THAT THE ALLOGRAFTS OR OTHER COMPONENTS MAY HAVE CAUSED THIS PT'S ASPERGILLUS INFECTION. ADDITIONAL INFO OBTAINED FROM (B) (6) ON APRIL 12, 2010: THE PT INITIALLY UNDERWENT A REPAIR OF THE AAA ON (B) (6) 2010. THE PHYSICIAN WAS DR (B) (6). THE ORIGINAL FACILITY WAS NOT REPORTED. THERE WERE TWO MAQUET CARDIOVASCULAR GRAFTS USED IN THE PROCEDURE, BOTH WITH UNK BATCH NUMBERS. ONE DEVICE WAS A (B) (6), WITH AN EXPIRATION DATE OF JANUARY 1, 2014. THE OTHER WAS A (B) (6), WITH AN EXPIRATION DATE OF AUGUST 1, 2014. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THESE DEVICES. CRYOLIFE BIOGLUE WAS ALSO USED DURING THE PROCEDURE. THERE WERE NO COMPLICATIONS. THE PT WAS LATER TRANSFERRED TO THE (B) (6) HOSPITAL AND CLINIC, EXACT DATE UNK. THE PT EXPIRED ON (B) (6) 2010. (B) (6) ALSO CONFIRMED THE ORIGINAL INFO REPORTED TO US ON APRIL 6, 2010 BY THE FDA REPRESENTATIVE. BEING INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT SEALED VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC 175828P UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death