BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2874550 · Received December 15, 2012

    Report

    Report Number
    2954761-2012-00050
    Event Type
    Injury
    Date Received
    December 15, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A SINGLE COMPLAINT REGARDING VERITAS MESH DISLODGEMENT ON A MALE PATIENT WHO HAS UNDERGONE THREE PREVIOUS HERNIA REPAIRS FOR THE SAME HERNIA. AT RE-OPERATION, IT WAS EVIDENT THAT THE SUTURES PLACED TO SECURE THE MESH HAS TORN COMPLETELY THROUGH THE VERITAS. TEARING OF SUTURES THROUGH THE VERITAS TISSUE CAN OCCUR WHEN THE CHOICE OF SUTURES IS TOO LARGE, CREATING SMALL DEFECTS IN THE VERITAS TISSUE OR IF THE SUTURES ARE PLACED UNDER SIGNIFICANT TENSION. DURING THE POST OPERATIVE PERIOD, ANY INCREASE IN INTRA-ABDOMINAL PRESSURE SUCH AS THAT CAUSED BY COUGHING, WOULD PLACE EACH SUTURE AND SMALL TISSUE DEFECT UNDER INCREASING STRESS AND LEAD TO EVENTUAL TEARING OF THE IMPLANT MATERIAL. AS THIS WAS THE SURGEON'S FIRST EXPOSURE TO VERITAS MESH IMPLANTATION, AND NO INTRA-OPERATIVE GUIDANCE WAS ABLE TO BE GIVEN, THE DIFFERENCE IN HANDLING OF VERITAS AS COMPARED TO OTHER HERNIA REPAIR MESHES ON THE MARKET LIKELY CONTRIBUTED TO THE DISLODGEMENT OF THE IMPLANT. IF THE SURGEON INTENDS TO USE VERITAS AGAIN, EVERY EFFORT SHOULD BE MADE TO ENSURE THE LOCAL TERRITORY BUSINESS MANAGER IS THERE TO PROVIDE APPROPRIATE GUIDANCE INTRA-OPERATIVELY. THE SAMPLE HAS CURRENTLY BEEN REQUESTED AND AN INVESTIGATION IS UNDERWAY AT THE MANUFACTURING FACILITY. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION CONFIRMED RIPPED SUTURE LINES AND DISCOVERED NO EVIDENCE OF PRODUCT FAILURE. BATCH REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. LABELING REVIEW WAS FOUND TO BE ACCURATE AND SUFFICIENT. NO TREND WAS IDENTIFIED AND THE LABELING IS APPROPRIATE. THE MANUFACTURING FACILITY CONCLUDED THE ROOT CAUSE COULD NOT BE DETERMINED. PER THE BAXTER MEDICAL ASSESSMENT THE BAXTER SALES REPRESENTATIVE FOLLOWED UP WITH THE REPORTER AND REVIEWED THE IFU REGARDING THE APPROPRIATE USE OF THE PRODUCT. SHE ALSO DID AN IN-SERVICE TO DR. WARD AND STAFF REGARDING APPROPRIATE USE/TECHNIQUE OF VERITAS. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE SURGEON INSERTED VERITAS MESH LAST WEEK AND IT WAS REPORTED THE PATIENT HAD POST-OPERATIVE COUGHING. THE SURGEON FELT A POPPING NOISE IN THE PATIENT'S BELLY AND IT WAS DISCOVERED THAT THERE WAS SOME EXTRUSION FROM THE HERNIA SITE. THE SURGEON PERFORMED CORRECTIVE SURGERY IN WHICH VERITAS WAS TAKEN OUT AND WAS REPLACED WITH A NEW ONE. ADDITIONAL INFORMATION: MEDICAL HISTORY: PATIENT HAS A LONG HISTORY OF SMOKING AND THE INITIAL SURGERY WAS REFUSED BY DR. (B)(6) UNTIL HE STOPPED SMOKING FOR 6 MONTHS. AS REPORTED ASSESSMENT: SURGEON BELIEVES THAT THE VERITAS MESH FAILED TO HOLD THE SUTURES WHEN THE PATIENT COUGHED POST-OPERATIVELY. BAXTER WAS INFORMED BY THE LOCAL REPRESENTATIVE THAT THIS WAS THE SURGEON'S FIRST TIME USING THE PRODUCT. HER CONCERN IS THAT THIS WAS THE PATIENT'S 4TH SURGERY TO REPAIR THIS HERNIA AND BOTH THE PATIENT'S TISSUE AS WELL AS THE SURGEON'S LACK OF EXPERIENCE WITH THE PRODUCT MAY HAVE CONTRIBUTED TO THE PRODUCT BEING SUTURED IN PLACE UNDER TOO MUCH TENSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other