BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAVESS BOVINE PERICARDIAL

    MDR report key: 11697594 · Received April 20, 2021

    Report

    Report Number
    2015691-2021-02581
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    January 13, 2021
    Report Date
    April 20, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    PSQ
    PMA / PMN Number
    K172660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. THESE DEVICES ARE USED BY HIGHLY TRAINED CLINICIANS, EXPERIENCED IN IDENTIFYING AND MITIGATING ANY HAZARDS THAT ARISE DURING USE. IN ADDITION, THESE DEVICES ARE TYPICALLY USED FOR OPERATIVE PATIENTS AND THE PATIENTS ARE RECOVERED IN THE INTENSIVE CARE. IT IS UNKNOWN WHAT SEQUELA OCCURRED TO CAUSE THE PHYSICIAN TO ASSUME THIS IS AN ISSUE ATTRIBUTED TO THE DURAVESS PATCH. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EXCESSIVE BLEEDING AT THE SUTURE LINE. THE DOCTOR WILL NOT GIVE ANY FURTHER DETAILS UNTIL AN IN-SERVING IS CONDUCTED. HOWEVER, AT THIS TIME THE HOSPITAL IS ON LOCKDOWN DUE TO A RISE IN COVID CASES. NO ADDITIONAL DETAILS CAN BE PROVIDED AT THIS TIME. IT IS UNKNOWN HOW MUCH BLOOD WAS LOST OR IF ANY ADDITIONAL PROCEDURES WERE DONE, WHAT THE ORIGINAL PROCEDURE WAS AND WHAT THE PATIENT STATUS IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590639 DURAVESS BOVINE PERICARDIAL INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED PSQ EDWARDS LIFESCIENCES DP2X9 62930532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other