BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 11181465 · Received January 15, 2021

    Report

    Report Number
    3009897021-2021-00007
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    November 1, 2014
    Report Date
    February 12, 2021
    Manufacturer
    KINETIC CONCEPTS, INC
    Product Code
    OMP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MDR-3009897021-2021-00007_121099-ISS SUBMITTED ON 15-JAN-2021 NOTED THE FOLLOWING: SECTION G6 TYPE OF REPORT: 30-DAY AND INITIAL WERE SELECTED. SECTION H10 ADDITIONAL MANUFACTURER NARRATIVE: SECTION H3: OTHER (CODE UNSPECIFIED, DESCRIBE IN H10): THE DEVICE TYPE AND IDENTIFIER WERE NOT PROVIDED 01-M. CORRECTIONS: SECTION G6 TYPE OF REPORT: 30-DAY. SECTION H10 ADDITIONAL MANUFACTURER NARRATIVE: SECTION H3: OTHER (CODE UNSPECIFIED, DESCRIBE IN H10): THE DEVICE TYPE AND IDENTIFIER WERE NOT PROVIDED. SECTION H6 ADVERSE EVENT PROBLEMS WERE UPDATED TO REFLECT CORRECT CODES. BASED ON THE CORRECTIONS PROVIDED, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED FISTULA IS RELATED TO V.A.C.® THERAPY. THE POSSIBLE ROOT CAUSE / CAUSATIVE FACTORS AND CONCLUSION FOR THIS IS EVENT IS POTENTIAL USE ERROR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE ARTICLE INCLUDED NON-TRAUMA ADULT PATIENTS REQUIRING EMERGENCY ABDOMINAL SURGERY WERE INCLUDED BETWEEN (B)(6) 2014 AND (B)(6) 2017. THE EXACT DATE OF THE EVENT IS UNKNOWN. OTHER (CODE UNSPECIFIED): THE DEVICE TYPE AND DENTIFIER WERE NOT PROVIDED01-M. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED FISTULA IS RELATED TO V.A.C.® THERAPY. IT IS UNKNOWN IF AND WHAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO RESOLVE THE FISTULA. KCI HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL AND DEVICE INFORMATION. THE V.A.C.® THERAPY UNIT TYPE AND IDENTIFIER WERE NOT PROVIDED, AND THE PRODUCT WAS NOT RETURNED, AND AS A RESULT, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE ARTICLE NOTED THAT "INVESTIGATION OF THE PATIENT WITH BIOLOGICAL MESH IN WHOM A FISTULA DEVELOPED, WE FOUND THAT THE STANDARD NPW [NEGATIVE PRESSURE WOUND] THERAPY WAS APPLIED DIRECTLY ONTO THE BIOLOGICAL MESH WITHOUT USING MEPITEL® OR ADAPTIC® AS AN INTERFACE ACCORDING TO STUDY PROTOCOL." THEREFORE, THE POSSIBLE ROOT CAUSE/CAUSATIVE FACTORS AND CONCLUSION FOR THIS IS EVENT IS POTENTIAL USE ERROR. V.A.C.® THERAPY DEVICE LABELING, AVAILABLE IN PRINT IN ONLINE, STATES: PRECAUTIONS: CONTINUOUS VERSUS INTERMITTENT / DPC V.A.C.® THERAPY: CONTINUOUS THERAPY IS ALSO GENERALLY RECOMMENDED FOR PATIENTS AT INCREASED RISK OF BLEEDING, HIGHLY EXUDATING WOUNDS, FRESH FLAPS AND GRAFTS, AND WOUNDS WITH ACUTE ENTERIC FISTULAE. V.A.C.® FOAM CAN BE PLACED DIRECTLY OVER SYNTHETIC MESH IN ABDOMINAL WOUNDS WITHOUT EXPOSED VISCERA AND CAN FACILITATE THE GROWTH OF GRANULATION TISSUE FROM THE STRUCTURES BENEATH THE MESH, EXTENDING UP THROUGH THE MESH INTO THE WOUND BASE. MESHED GRAFTS: APPLY V.A.C. ® DRESSING IMMEDIATELY AFTER GRAFT PLACEMENT AND BEGIN THERAPY AS SOON AS POSSIBLE. WHEN USING V.A.C.® GRANUFOAM¿ DRESSINGS, A NON-ADHERENT DRESSING SHOULD BE PLACED DIRECTLY OVER THE GRAFT / TISSUE. IN GENERAL, THE PRESSURE SETTING USED TO PREPARE THE RECIPIENT BED BEFORE GRAFTING SHOULD BE CONTINUED AFTER GRAFTING. CONTINUOUS THERAPY SHOULD BE USED TO PROVIDE A CONSTANT BOLSTER. RECOMMENDED SETTINGS FOR MESHED GRAFTS AND DERMAL SUBSTITUTES: INITIAL CYCLE CONTINUOUS FOR DURATION OF THERAPY. TARGET PRESSURE V.A.C.® GRANUFOAM¿ DRESSING 75 - 125 MMHG. TARGET PRESSURE V.A.C.® WHITEFOAM¿ DRESSING 125 MMHG, TITRATE UP FOR MORE DRAINAGE. DRESSING CHANGE INTERVAL: REMOVE DRESSING AFTER 4 - 5 DAYS WHEN USING EITHER FOAM (DRAINAGE SHOULD TAPER OFF BEFORE REMOVAL).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI AFTER A REVIEW OF JOURNAL ARTICLE, FLEUR E.E. ET AL. IMMEDIATE CLOSURE OF ABDOMINAL CAVITY WITH BIOLOGIC MESH VERSUS TEMPORARY ABDOMINAL CLOSURE OF OPEN ABDOMEN IN NON-TRAUMA EMERGENCY PATIENTS (CLOSE-UP STUDY). SURG INFECTION. VOL 21;8 (2020). DOI:10.1089/SUR.2019.289 NOTED THE FOLLOWING ON PAGE 699: "ON INVESTIGATION OF THE PATIENT WITH BIOLOGICAL MESH IN WHOM A FISTULA DEVELOPED, WE FOUND THAT THE STANDARD NPW [NEGATIVE PRESSURE WOUND] THERAPY WAS APPLIED DIRECTLY ONTO THE BIOLOGICAL MESH WITHOUT USING MEPITEL® OR ADAPTIC® AS AN INTERFACE ACCORDING TO STUDY PROTOCOL." ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI FROM THE AUTHOR: THE SITUATION DESCRIBED AT PAGE 699 IS A FISTULA POSSIBLY RELATED TO STANDARD NPWT [NEGATIVE PRESSURE WOUND THERAPY] ON TOP OF A BRIDGING STRATTICE. THE STANDARD NPWT DEVICE IS NOT ABTHERA¿ THERAPY AND THIS EVENT DOES NOT HAVE ANYTHING TO DO WITH ABTHERA¿ THERAPY. THE EVENT OCCURRED IN THE BIOMESH GROUP. THERE ARE NO ADDITIONAL DETAILS REGARDING THE FISTULA OR DEVICE TYPE AS THE EVENT OCCURRED AT A DIFFERENT FACILITY. THE V.A.C.® THERAPY UNIT IDENTIFIER WAS NOT PROVIDED AND THE PRODUCT WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72912 V.A.C. THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC UNKVAC

    Patients

    Seq Age Sex Outcome Treatment
    1