BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN HERNIA GRAFT

    MDR report key: 7214926 · Received January 24, 2018

    Report

    Report Number
    1835959-2018-00002
    Event Type
    Injury
    Date Received
    January 24, 2018
    Report Date
    February 12, 2018
    Manufacturer
    COOK BIOTECH
    Product Code
    OXK
    UDI-DI
    10827002482163
    PMA / PMN Number
    K133306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DEVIATION WOULD NOT HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE. A TOTAL OF TWO (2) DEVICES WAS PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. A REVIEW OF THE IFU INDICATED THAT SEROMA FORMATION AND INFECTION (IRRESPECTIVE OF ONE ANOTHER) ARE NOTED IN THE POTENTIAL COMPLICATIONS AS SOME OF THE "POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY PROSTHESIS." IN ADDITION, THE IFU NOTES THAT ¿COMPLICATIONS, SUCH AS DELAYED WOUND INFECTION, PREMATURE DEGRADATION, HERNIA RECURRENCE, BOWEL EROSION, AND THE NEED FOR RE-OPERATION, SHOULD BE REASONABLY EXPECTED IN PATIENTS WHO ARE CRITICALLY ILL OR WHO HAVE SEVERELY CONTAMINATED ABDOMENS." THE ROOT CAUSE OF THE SEROMA IS LIKELY RELATED TO THE EXTENSIVE DISRUPTION OF TISSUE THAT OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, SEROMA FORMATION IS A KNOWN INHERENT RISK OF THE SURGICAL PROCEDURE AND IS A KNOWN POTENTIAL OUTCOME WITH THE USE OF ANY PROSTHESIS. UPDATE: THE ORIGINAL INVESTIGATION AND ROOT CAUSE ANALYSIS REMAIN UNCHANGED. HOWEVER, IN ADDITION, THE LIKELY ROOT CAUSE OF THE BACTERIA NOTED FROM THE (B)(6) 2018 OPERATION WAS LIKELY INTRODUCED DURING THE PERCUTANEOUS DRAINAGE ATTEMPT OR AFTER.

    Description of Event or Problem · 0

    ON (B)(6) 2017, DR. (B)(6) PLACED A C-SLH-8H-20X30 IN A (B)(6) MALE PATIENT. THE PATIENT HAD A PRIOR PLACEMENT OF POLYPROPYLENE MESH WHICH BECAME INFECTED. THE INFECTED POLYPROPYLENE WAS REMOVED BY LAPAROSCOPY AND THE BIODESIGN HERNIA GRAFT WAS PLACED IN AN OPEN PROCEDURE. THE BIODESIGN WAS PLACED FOR REPAIR OF A VENTRAL HERNIA. SEROMA FLUID WAS DRAINED FOR APPROXIMATELY 28-30 DAYS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONCE THE DRAIN OUTPUT WAS BELOW 20 ML PER DAY. TWO (2) WEEKS LATER, APPROXIMATELY FIFTY (50) DAYS POST BIODESIGN PLACEMENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FEVER AND SEROMA FORMATION. THE SEROMA WAS UNABLE TO BE DRAINED DUE TO THICKNESS AND THE PATIENT UNDERWENT ADDITIONAL SURGERY TO ASSESS FOR INFECTION AND SEROMA. THE SEROMA WAS DESCRIBED AS THICK, 300 ML FLUID COLLECTION, AND A CAUSE WAS UNABLE TO BE FOUND. A TISSUE SPECIMEN WAS SENT FOR LABORATORY REVIEW. UPDATE: ADDITIONAL DETAILS, RECEIVED ON 02/06/2018, HELPED CLARIFY THE OCCURRENCE. AFTER THE BIODESIGN WAS PLACED ON (B)(6) 2017, THE DRAIN WAS REMOVED ON (B)(6) 2017 AS THE DRAIN WAS ONLY OUTPUTTING 10 ML PER DAY. PUS WAS NOTICED COMING OUT OF THE DRAIN SITE ON (B)(6) 2017. ON (B)(6) 2017, PERCUTANEOUS DRAINAGE OF THE SEROMA WAS ATTEMPTED, BUT DID NOT DRAIN COMPLETELY DUE TO THE THICKNESS OF THE SEROMA. LAB RESULTS FOR THE FLUID FROM THE PERCUTANEOUS DRAINAGE WERE NEGATIVE. A DECISION TO PERFORM SURGERY TO EXCISE THE SEROMA WAS MADE. ON (B)(6) 2018, THE PATIENT UNDERWENT AN OPERATION TO DRAIN THE SEROMA. THE WOUND SIZE WAS 20.5 X 7X 18 CM AND ONE (1) LITER OF SEROMA FLUID WAS COLLECTED. THE BIODESIGN GRAFT WAS REPORTEDLY UNABLE TO BE IDENTIFIED DURING THIS PROCEDURE. LAB RESULTS FOR THE SEROMA COLLECTION INDICATED THE PRESENCE OF MILD COCCI BACTERIA. THE PATIENT WAS PLACED ON AN ANTIBIOTIC FOR FOURTEEN (14) DAYS. THE PATIENT HAD NOT RETURNED TO THE SURGEON SINCE THE (B)(6) 2018 OPERATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DEVIATION WOULD NOT HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE. A TOTAL OF TWO (2) DEVICES WAS PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. A REVIEW OF THE IFU INDICATED THAT SEROMA FORMATION AND INFECTION (IRRESPECTIVE OF ONE ANOTHER) ARE NOTED IN THE POTENTIAL COMPLICATIONS AS SOME OF THE "POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY PROSTHESIS." IN ADDITION, THE IFU NOTES THAT ¿COMPLICATIONS, SUCH AS DELAYED WOUND INFECTION, PREMATURE DEGRADATION, HERNIA RECURRENCE, BOWEL EROSION, AND THE NEED FOR RE-OPERATION, SHOULD BE REASONABLY EXPECTED IN PATIENTS WHO ARE CRITICALLY ILL OR WHO HAVE SEVERELY CONTAMINATED ABDOMENS." THE ROOT CAUSE OF THE SEROMA IS LIKELY RELATED TO THE EXTENSIVE DISRUPTION OF TISSUE THAT OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, SEROMA FORMATION IS A KNOWN INHERENT RISK OF THE SURGICAL PROCEDURE AND IS A KNOWN POTENTIAL OUTCOME WITH THE USE OF ANY PROSTHESIS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, DR. (B)(6) PLACED A C-SLH-8H-20X30 IN A (B)(6) MALE PATIENT. THE PATIENT HAD A PRIOR PLACEMENT OF POLYPROPYLENE MESH WHICH BECAME INFECTED. THE INFECTED POLYPROPYLENE WAS REMOVED BY LAPAROSCOPY AND THE BIODESIGN HERNIA GRAFT WAS PLACED IN AN OPEN PROCEDURE. THE BIODESIGN WAS PLACED FOR REPAIR OF A VENTRAL HERNIA. SEROMA FLUID WAS DRAINED FOR APPROXIMATELY 28-30 DAYS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONCE THE DRAIN OUTPUT WAS BELOW 20 ML PER DAY. TWO (2) WEEKS LATER, APPROXIMATELY FIFTY (50) DAYS POST BIODESIGN PLACEMENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FEVER AND SEROMA FORMATION. THE SEROMA WAS UNABLE TO BE DRAINED DUE TO THICKNESS AND THE PATIENT UNDERWENT ADDITIONAL SURGERY TO ASSESS FOR INFECTION AND SEROMA. THE SEROMA WAS DESCRIBED AS THICK, 300 ML FLUID COLLECTION, AND A CAUSE WAS UNABLE TO BE FOUND. A TISSUE SPECIMEN WAS SENT FOR LABORATORY REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61052 BIODESIGN HERNIA GRAFT HERNIA GRAFT OXK COOK BIOTECH G48216 10827002482163

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention NONE WERE REPORTED BY THE COMPLAINANT.| NONE WERE REPORTED BY THE COMPLAINANT.| NONE WERE REPORTED BY THE COMPLAINANT.