BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS

    MDR report key: 7432720 · Received April 16, 2018

    Report

    Report Number
    1416980-2018-02165
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    May 31, 2018
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS RELATED TO MANUFACTURER REPORT NUMBER (B)(4). (B)(6). THIS REPORT WAS RECEIVED FROM A PHYSICIAN AND REFERENCED LITERATURE ARTICLE FROM THE EUROPEAN JOURNAL OF PLASTIC SURGERY/10.1007/S00238-017-1389-5 TITLED: COMPLETE RESORPTION OF VERITAS IN ACELLULAR DERMAL MATRIX (ADM)-ASSISTED IMPLANT -BASES BREAST RECONSTRUCTIONS-IS THERE A NEED FOR TIGHTER REGULATION OF NEW PRODUCTS DEVELOPED FOR USE IN BREAST RECONSTRUCTION?, FAYYAZ A. K. MAZARI; KRISTJAN S. ASGEIRSSON, LISA WHISKER, ELEANOR GUTTERIDGE, TUABIN RASHEED, R. DOURGLAS MACMILLAN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED COMPLETE RESORPTION OF VERITAS WHICH CAUSED A SEROMA, AFTER UNDERGOING A SURGERY IN WHICH VERITAS WAS USED. THE RESORPTION WAS FURTHER DESCRIBED AS ¿BOTTOMING OUT OF THE IMPLANT¿ WHICH REQUIRED REVISION SURGERY. THE PATIENT HAD UNDERGONE BREAST RECONSTRUCTION SURGERY. THE IMPLANTS WERE PLACED PARTIALLY UNDER THE PECTORALIS MAJOR MUSCLE WITH VERITAS USED TO COVER THE LOWER POLE OF THE IMPLANT AND SUTURED TO THE PECTORALIS MAJOR MUSCLE SUPERIORLY TO HOLD THE DETACHED END OF THE MUSCLE IN POSITION AND TO THE CHEST WALL INFERIORLY AND LATERALLY. SUBSEQUENTLY, ON RETURN TO THE SURGICAL THEATRE FOR THE EXPANDER REMOVAL AND INSERTION OF THE FINAL IMPLANT, THE SURGEON NOTED THAT THERE WAS NO VERITAS AND/OR NO INTEGRATION OF LOWER POLE, THE VERITAS COLLAGEN MATRIX WAS DISSOLVED LEAVING ONLY A YELLOW, GEL-LIKE SEROMA IN THE IMPLANT CAVITY. THIS REQUIRED THE PATIENT TO UNDERGO REVISION SURGERY (DATE UNSPECIFIED). NO FURTHER DETAIL WAS PROVIDED REGARDING THE PATIENT¿S OUTCOME FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276675 VERITAS MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS NA SPCE314-08H0018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MONOFILAMENT SUTURES(2-0)