BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 1940792 · Received December 22, 2010

    Report

    Report Number
    2183620-2010-00069
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE MET SPEC AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT A UNILATERAL SIMPLE LEFT BREAST MASTECTOMY AND SENTINEL NODE BIOPSY WITH IMMEDIATE RECONSTRUCTION AND SUB-PECTORAL PLACEMENT OF SILICONE BREAST IMPLANT. A 10 X 16 VERITAS PATCH WAS ANCHORED IN PLACE ALONG THE INFRA-MAMMARY FOLD UTILIZING INTERRUPTED 2-0 PDS SUTURE. THE BREAST IMPLANT WAS PLACED IN THE VERITAS POCKET AND A SINGLE #10 JACKSON-PRATT DRAIN WAS PLACED BETWEEN THE IMPLANT AND VERITAS PATCH. THE SKIN WAS CLOSED AND THE PT WAS PLACED IN A SPECIAL BRA FOR THE RECOVERY PERIOD. THE PT WAS ALSO PROVIDED A POST-OPERATIVE 7-DAY COURSE OF KEFLEX ANTIBIOTIC THERAPY PER THE PHYSICIAN'S ROUTINE PROTOCOL. APPROX 7-10 DAYS POST PROCEDURE, THE DRAIN WAS PULLED WHEN OUTPUT WAS LESS THAN 10CC/DAY. THE PHYSICIAN REPORTED THAT THE PT WAS "ACTIVE", "NON-COMPLIANT", BUT HAD NOT BEEN WEARING THE RECOMMENDED BRA. AT APPROX 2 WEEKS POST PROCEDURE, PT HAD DEVELOPED A SEROMA WHICH WAS "AGGRESSIVELY" DRAINED OVER THE COURSE OF THE NEXT FEW WEEKS BY ASPIRATING THE SEROMA VIA NEEDLE AND SYRINGE IN EVERY OTHER DAY INTERVALS. IT WAS NOTED THAT THERE WAS APPROX 80-100 CC OF SERUM ASPIRATED INITIALLY BUT THE AMOUNT DECREASED WITH THE REPEATED ASPIRATIONS OVER A TWO WEEK PERIOD. A CULTURE OF THE SEROUS FLUID WAS TAKEN AND LABORATORY ANALYSIS REVEALED NO BACTERIAL GROWTH. AS A PREVENTIVE MEASURE, THE PHYSICIAN PRESCRIBED THE ANTIBIOTIC BACTRIM FOR AN UNSPECIFIED DURATION. AFTER TWO WEEKS OF ASPIRATIONS, THE PHYSICIAN NOTED THAT THE IMPLANT HAD SLID INTO THE LEFT LATERAL CHEST WALL. THE PHYSICIAN THOUGHT THIS MAY HAVE BEEN DUE TO THE LATERAL SUTURES PULLING AWAY FROM THE VERITAS IMPLANT DUE TO THE PT'S ACTIVITY COMBINED WITH NOT WEARING THE RECOMMENDED BRA. THE PT WAS ADVISED TO BEGIN WEARING THE RECOMMENDED BRA, WHICH THE PT DID COMPLY. A FEW DAYS LATER, IT WAS NOTED THAT THE IMPLANT REMAINED IN THE CORRECT POSITION AND IT WAS BELIEVED THE LATERAL BORDER HAD SCARRED DOWN. ON (B)(6) 2010, THE PT WAS TAKEN BACK TO THE OPERATING ROOM TO PERFORM AN IMPLANT PROCEDURES ON THE RIGHT BREAST (OPPOSITE SIDE). THE PHYSICIAN NOTED THAT THE LEFT BREAST IMPLANT HAD AGAIN SLID INTO THE LEFT LATERAL CHEST AREA. EXPLORATION OF THE LEFT BREAST AREA NOTED THAT THE VERITAS PATCH HAD COMPLETELY PULLED AWAY FROM THE INFRA-MAMMARY AREA AND THE BREAST IMPLANT RESIDED ON TOP OF THE VERITAS PATCH. THE 2-0 PDS SUTURE WHICH HELD THE VERITAS IN PLACE REMAINED IN THE SUBCUTANEOUS TISSUE. THERE WAS NO FOUL ODOR OR DRAINAGE NOTED. THE VERITAS PATCH SHOWED NO SIGNS OF VASCULARISATION. WHEN THE PHYSICIAN LIFTED UP THE VERITAS PATCH, THE TISSUE "DISINTEGRATED". CULTURES WERE TAKEN AND LAB ANALYSIS REVEALED NO BACTERIAL GROWTH. AN ALTERNATIVE SURGICAL MESH WAS IN BOTH SIDES OF THE BREAST RECONSTRUCTION. AT 5 DAYS POST OP, THE PT IS REPORTED TO BE DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS COLLAGEN MATRIX SURGICAL MESH FTM SYNOVIS SURGICAL INNOVATIONS RM 1016 5771722-13745598

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention