BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 3040907 · Received April 8, 2013

    Report

    Report Number
    2032282-2013-00034
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VERITAS MESH IS A RESORBABLE COLLAGEN MATRIX. IT APPEARS THAT THE MESH HAS RUPTURED AFTER IMPLANTATION IN A SPOT WHERE A SUTURE HAS BEEN APPLIED. THIS RESULTED IN A SMALL HERNIA RECURRENCE. VERITAS COLLAGEN MATRIX ALLOWS FOR NEO-COLLAGEN FORMATION AND NEOVASCULARIZATION OF THE IMPLANTED DEVICE AND PERMITS REPLACEMENT OF THE DEVICE WITH HOST TISSUE, OR REMODELING. IT APPEARS THAT THE MESH RUPTURED IN THE EARLY POSTOPERATIVE PHASE, BEFORE REMODELING OCCURRED. IN HIGH-RISK PATIENTS THE USE OF RESORBABLE MESHES IS CONTROVERSIAL. EITHER THE INTRA-ABDOMINAL PRESSURE HAS BEEN TOO HIGH OR THE PHYSICAL RESISTANCE OF THE MESH DURING REMODELING HAS BEEN TOO LOW. ANOTHER PRECAUTION THAT HAS TO BE TAKEN INTO ACCOUNT IS TO AVOID TENSION ON THE MATERIAL. THE DEVICE RUPTURE MAY BE POSSIBLY RELATED TO THE USE OF THE VERITAS MESH. REVIEW OF THE PRODUCT PROPERTIES AND APPLICATION WITH THE REPORTING SURGEON (IFU) IS RECOMMENDED. BAXTER IS STILL FOLLOWING UP WITH THE REPORTER FOR ADDITIONAL INFORMATION AND REVIEW OF PRODUCT INSTRUCTIONS FOR USE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON REVIEW AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER CONTACTED THE CUSTOMER SITE AND THEY EXPRESSED THEY DO NOT WISH TO PROVIDE ANY FURTHER CASE DETAILS. DUE TO THE LACK OF INFORMATION A FINAL CAUSAL RELATIONSHIP CANNOT BE DETERMINED.BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE AND LOT NUMBER WERE PROVIDED. PER SYNOVIS, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE ROOT CAUSE IS UNDETERMINABLE AT THIS TIME AND NOT FURTHER INVESTIGATION IS NECESSARY.THE COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO BAXTER THAT A PATIENT HAD A SMALL REOCCURRENCE WHERE THE SUTURE WAS IN THE VERITAS. EVERY OTHER AREA LOOKED FINE; HOWEVER, ONLY THE ONE AREA HAD THE PROBLEM. VERITAS WAS IMPLANTED IN THE ABDOMEN ABOUT A YEAR AND HALF AGO. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143881 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other