BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABTHERA¿ NEGATIVE PRESSURE THERAPY UNIT

    MDR report key: 5774743 · Received July 7, 2016

    Report

    Report Number
    3009897021-2016-00058
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    September 1, 2005
    Report Date
    July 7, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K083357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S INCLUDED IN THIS STUDY WERE TREATED WITH ABTHERA THERAPY FROM SEP 2005 TO AUG 2014. IT IS UNKNOWN WHEN THE EVENTS OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED ENTEROATMOSPHERIC FISTULAS ARE RELATED TO ABTHERA THERAPY. THE PATIENTS IN THIS STUDY HAD AN OPEN ABDOMEN DUE TO SECONDARY PERITONITIS AND IT WAS NOTED IN THE ARTICLE THAT "PERITONITIS IS CONSIDERED TO BE AN INDEPENDENT RISK FACTOR WHICH COULD RESULT IN FAILURE TO ACHIEVE DELAYED FASCIAL CLOSURE AND INCREASE THE RATES OF FISTULA FORMATION." THE PATIENTS' PRE-EXISTING CONDITION ITSELF POSES A RISK OF FISTULA FORMATION REGARDLESS OF THE USE OF ABTHERA THERAPY. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: CONTRAINDICATIONS: PATIENTS WITH OPEN ABDOMINAL WOUNDS CONTAINING NON-ENTERIC AND UNEXPLORED FISTULAS SHOULD NOT BE TREATED WITH THE ABTHERA NPT SYSTEM. WARNINGS: ADHESIONS AND FISTULA DEVELOPMENT: FORMATION OF ADHESIONS OF THE VISCERA TO THE ABDOMINAL WALL MAY REDUCE THE LIKELIHOOD OF FASCIAL REAPPROXIMATION AND INCREASE THE RISK OF FISTULA DEVELOPMENT, WHICH ARE COMMON COMPLICATIONS IN PATIENTS WITH EXPOSED VISCERA. INFECTION: INFECTED ABDOMINAL WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS PATIENT CONDITION, WOUND CONDITION AND TREATMENT GOALS. DEVICE IDENTIFIERS UNKNOWN.

    Description of Event or Problem · 1

    ON JUN 27 2016, KCI RECEIVED ARTICLE, MINTZIRAS, IOANNIS, ET AL. HIGH RISK OF FISTULA FORMATION IN VACUUM-ASSISTED CLOSURE THERAPY IN PATIENTS WITH OPEN ABDOMEN DUE TO SECONDARY PERITONITIS-A RETROSPECTIVE ANALYSIS. LANGENBECKS ARCH SURG. 2016 MAY 5; 1-7. DOI: 10.1007/S00423-016-1443-Y THAT REPORTED THE FOLLOWING: "THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF VACUUM-ASSISTED CLOSURE THERAPY IN PATIENTS WITH OPEN ABDOMEN DUE TO SECONDARY PERITONITIS AND TO IDENTIFY POSSIBLE RISK FACTORS OF FISTULA FORMATION. RESULT: ...OVERALL 16 OF THE 43 PATIENTS DEVELOPED ENTEROATMOSPHERIC FISTULA. RE-EXPLORATIONS AFTER STARTING V.A.C. TREATMENT AND DURATION OF V.A.C.THERAPY WERE SIGNIFICANTLY ASSOCIATED WITH THE OCCURRENCE OF ENTEROATMOSPHERIC FISTULAS... CONCLUSIONS LONG-TERM V.A.C. TREATMENT OF PATIENT WITH AN OPEN ABDOMEN DUE TO SECONDARY PERITONITIS RESULTS IN A RELATIVELY LOW FASCIAL CLOSURE RATE AND A HIGH RISK OF FISTULA FORMATION. ADDITIONAL INFORMATION: SIXTEEN (16) OF 43 PATIENTS DEVELOPED ENTEROATMOSPHERIC FISTULAS THAT REQUIRED A TOTAL OF 71 RE-OPERATIONS. SEVEN ENTEROATMOSPHERIC FISTULAS COULD BE DEFINITIVELY CLOSED BY IMMEDIATE REOPERATION. IN THOSE CASES A SEGMENTAL SMALL BOWEL RESECTION (JEJUNUM OR ILEUM) WITH ANASTOMOSIS WAS PERFORMED. THREE COULD BE CLOSED BY A REOPERATION AFTER A TIME INTERVAL OF AT LEAST 3 MONTHS. IN ONE CASE THE FISTULA COULD BE CLOSED WITH SUTURES. IN THE SECOND CASE A SEGMENTAL SMALL BOWEL RESECTION AS WELL AS SUTURING OF THE FISTULA WERE REQUIRED. IN THIS CASE SPLIT-THICKNESS SKIN GRAFTING (MESH GRAFT) WAS EMPLOYED IN ORDER TO ACHIEVE WOUND CLOSURE. IN THE THIRD CASE A T-TUBE DRAINAGE WAS INSERTED IN THE SMALL BOWEL FISTULA, WHICH WAS THEN TREATED WITH A LAPAROSTOMY BAG. ON JUL 05 2016, KCI RECEIVED THE FOLLOWING INFORMATION FROM THE PHYSICIAN: "A LIMITATION OF AN OBSERVATIONAL STUDY IS THAT STATISTICAL ANALYSIS CAN ONLY IDENTIFY ASSOCIATIONS BETWEEN INDEPENDENT VARIABLES AND THE OUTCOME OF INTEREST. CAUSALITY CANNOT BE ESTABLISHED WITHIN RETROSPECTIVE OBSERVATIONAL STUDIES... FOR THESE REASONS WE CANNOT EITHER DENY OR CONFIRM THAT A CAUSE-AND-EFFECT RELATIONSHIP TRULY EXISTS. OPTIMAL DURATION OF THERAPY IS ACCORDING TO OUR OPINION THOUGH A CRITICAL ISSUE WHEN IT COMES TO PATIENTS WITH SEVERE ABDOMINAL SEPSIS. OUR AIM WAS MAINLY TO DRAW ATTENTION TO THIS SIGNIFICANT ISSUE IN ORDER TO DIFFERENTIATE SUCH PATIENTS FROM PATIENTS WITH LOW OR NO RISK OF FISTULA FORMATIONS, E.G. TRAUMA PATIENTS. THIS IS ONE OF THE FIRST STUDIES WHICH ADDRESSES THE MAJOR ISSUE OF THE OPTIMAL DURATION OF THERAPY TO AVOID SEVERE COMPLICATIONS. DUE TO THE RETROSPECTIVE NATURE OF THE STUDY ARE UNFORTUNATELY NO SERIAL NUMBERS AVAILABLE." THE PHYSICIAN CONFIRMED THAT THE SPECIFIC DEVICE INFORMATION WAS NOT AVAILABLE, THEREFORE KCI CANNOT CONDUCT DEVICE EVALUATIONS OF THE UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429498 ABTHERA¿ NEGATIVE PRESSURE THERAPY UNIT OMP OMP KCI USA, INC. WNDABT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention