BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRALIGHT ST MESH

    MDR report key: 2766667 · Received September 25, 2012

    Report

    Report Number
    1213643-2012-00616
    Event Type
    Death
    Date Received
    September 25, 2012
    Date of Event
    August 26, 2012
    Report Date
    August 27, 2012
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K101851
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR INCLUDES ALL PT, EVENT, AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. REVIEW OF MEDICAL RECORDS SHOW THE PT HAD COMORBIDITIES INCLUDING OBESITY, BORDERLINE DIABETES, HYPERCOAGULABLE DISORDER, AS WELL AS OTHER ALLERGIES AND HEART DISORDERS. THE PT WAS IMPLANTED WITH A VENTRALIGHT ST MESH ON (B)(6) 2012. FIVE DAYS POST OPERATIVE, THE PT WAS ADMITTED WITH DISSEMINATED INTRAVASCULAR COAGULATION, FEVER, AND ABDOMINAL REDNESS. THE ABDOMINAL REDNESS WAS REPORTED TO HAVE RESOLVED WITHIN THE FIRST FEW DAYS OF HOSPITALIZATION. A CT SCAN WAS PERFORMED TWO DAYS AFTER THE PT WAS READMITTED AND SHOWED A SMALL HERNIA RECURRENCE. ON (B)(6) 2012, THE PT EXPIRED. THE CAUSE OF DEATH WAS LISTED AS MULTI-SYSTEM ORGAN FAILURE AND PEA-PULSELESS ELECTRICAL ACTIVITY OF UNCERTAIN ETIOLOGY. THE AUTOPSY REPORT, WHICH WAS PROVIDED TO DAVOL, IDENTIFIED SEVERAL TESTS THAT WERE PERFORMED ATTEMPTING TO IDENTIFY A CAUSE OF DEATH. IT IS NOTED WITHIN THE AUTOPSY REPORT THAT THE PT RECEIVED BLOOD TRANSFUSIONS, HOWEVER THE MEDICAL RECORDS PROVIDED DID NOT SHOW WHEN THESE TRANSFUSIONS OCCURRED. THE PT WAS FOUND TO HAVE CHRONIC ISCHEMIC HEART DISEASE WITH AN OLD TRANS-MURAL MYOCARDIAL INFARCT, AS WELL AS MODERATE TO SEVERE CORONARY ATHEROSCLEROSIS INVOLVING TWO OF THE MAIN CORONARY ARTERIES. THERE WAS EVIDENCE OF HYPERTENSIVE HEART DISEASE NOTED DURING THE AUTOPSY. THE AUTOPSY REPORT DID NOT IDENTIFY THE DAVOL MESH DEVICE TO BE DEFECTIVE OR AS HAVING CAUSED OR CONTRIBUTED TO THE PT'S DEATH. BASED ON THE INFO PROVIDED, NO DEFINITIVE CONCLUSION CAN BE MADE, HOWEVER THE MESH DOES NOT APPEAR TO HAVE BEEN CONTRIBUTORY TO THE DEATH OF THE PT. IF ADDITIONAL INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE SURGEON: IT WAS ALLEGED THAT IN (B)(6) 2012, THE PT WAS IMPLANTED WITH THE VENTRALIGHT MESH. TWO DAYS AFTER DISCHARGE FROM THE HOSPITAL, THE PT RETURNED WITH A LOW GRADE FEVER AND REDNESS ON THE ABDOMINAL SKIN. SIX DAYS LATER, THE PT DIED. THERE WAS NO DOCUMENTED INFECTION AND THE PT DID NOT APPEAR TO BE INFECTED. THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE SURGEON: ON (B)(6) 2012 - PT UNDERWENT LAPAROSCOPIC REPAIR OF AN INCARCERATED INCISIONAL HERNIA WITH VENTRALIGHT ST MESH. THE REPORTED BLOOD LOSS WAS 50 ML. THE PT'S HEMOGLOBIN AND HEMATOCRIT WERE BELOW NORMAL PRIOR TO AND AFTER THE SURGERY. ON (B)(6) 2012 - PT WAS ADMITTED WITH FEVER, DISSEMINATED INTRAVASCULAR COAGULATION, POST-OP PAIN, AND ABDOMINAL REDNESS THAT FADED OVER THE FIRST FEW DAYS OF HOSPITALIZATION. ON (B)(6) 2012 - PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRALIGHT ST MESH FTL DAVOL INC. NA HUWC0651

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death