BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2970541 · Received February 20, 2013

    Report

    Report Number
    2032282-2013-00023
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    July 27, 2012
    Report Date
    January 30, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS HAS COMPLETED THE INVESTIGATION. NO SAMPLE WAS AVAILABLE THEREFORE SAMPLE EVALUATION COULD NOT BE PERFORMED. BATCH RECORD REVIEW DETERMINED NO ISSUES WERE FOUND THAT COULD BE RELATED TO THE REPORTED CASE AND ALL RELEASE TESTING MET SPECIFICATIONS. THE MANUFACTURING FACILITY DETERMINED THAT IT IS NOT EVIDENT THAT THE USE OF THE PRODUCT RESULTED IN THE SEROMA OR THE TISSUE DISINTEGRATION THEREFORE NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. BAXTER (B)(4) WILL COMMUNICATE WITH THE COMPLAINANT REGARDING THE MEDICAL ASSESSMENT AND INVESTIGATION RESULTS. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CASE INFORMATION WAS RECEIVED ON (B)(6) 2013 FROM THE CUSTOMER AFTER MEETING WITH BAXTER'S MEDICAL ADVISOR. THE PHYSICIAN STATED THE PATIENT'S SEROMA WAS RESOLVED AND THE PRODUCT WAS REMOVED. THE PATIENT DOES HAVE A DEFORMITY BUT IT WILL BE REPAIRED IN DUE COURSE OF TIME, POSSIBLY WITH A PROSTHESIS. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE CAUSALITY OF THE ORIGINAL MEDICAL ASSESSMENT. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: BASED ON THE ADDITIONAL INFORMATION RECEIVED IT APPEARS THAT AFTER IMPLANTATION OF THE VERITAS COLLAGEN MATRIX TOGETHER WITH THE BREAST IMPLANT, THE PATIENT DEVELOPED PERSISTENT SEROMA THAT REQUIRED SURGICAL REINTERVENTION. DURING REVISION SURGERY THE VERITAS COLLAGEN IMPLANT WAS FOUND COMPLETELY FRAGMENTED INTO SEVERAL PIECES WITH NO ATTACHMENT, EITHER TO THE PECTORAL MUSCLE OR TO THE RECTUS FACIA AND NO EVIDENCE OF VASCULARISATION OR REGENERATION. THE EARLY DEGRADATION OF COLLAGEN IMPLANTS (ALL TYPES OF IMPLANTABLE MEDICAL DEVICES) IS A RARE BUT WELL KNOWN REACTION PATTERN IN THE PRESENCE OF AN INFLAMMATORY REACTION. THE DEFRAGMENTATION IT THE RESULT OF THIS DESCRIBED INFLAMMATORY REACTION WHICH PROBABLY PREVENTED REMODELING OF THE COLLAGEN IMPLANT. WHILE IT IS NOT POSSIBLE TO DETERMINE WHETHER THE VERITAS COLLAGEN MATRIX ITSELF OR OTHER SURGERY (EXTENSIVE COAGULATION, TISSUE MANIPULATION, THE BREAST IMPLANT, SUTURE MATERIAL) OR PATIENT RELATED FACTORS HAVE CAUSED THE INFLAMMATORY REACTION, WE CANNOT EXCLUDE THAT THE COLLAGEN IMPLANT HAS CAUSED OR CONTRIBUTED TO THE SEROMA FORMATION. ADDITIONAL FOLLOW-UP IS EXPECTED WITH THE REPORTING PHYSICIAN. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT A PATIENT UNDERWENT A BREAST SUBPECTORAL RECONSTRUCTION ON (B)(6) 2012 IN WHICH VERITAS MESH WAS USED. THE SURGEON NOTED THAT THE OPERATION WAS UNEVENTFUL BUT THE PATIENT HAD A PROLONGED DURATION OF SEROMA AND PERSISTENT DISCHARGE FROM THE MASTECTOMY SCAR. DURING (B)(6) 2012 ((B)(6)-MONTH POST-OPERATIVELY), THE SURGEON NOTICED THAT THE VERTIAS MESH HAD COMPLETELY DISINTEGRATED. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: CUSTOMER MENTIONED THAT FOLLOWING THE IMPLANTATION OF VERITAS FOR BREAST RECONSTRUCTION IN (B)(6) LAST YEAR, THE PATIENT HAD A PROLONGED DURATION OF SEROMA AND PERSISTENT DISCHARGE DUE TO WHICH HE HAD TO UNDERTAKE A RELOOK PROCEDURE AND THEN FOUND THAT THERE WERE 6-7 DISINTEGRATED PIECES OF VERITAS SUSPENDED IN FLUID, AND HE OBVIOUSLY HAD TO REMOVE THE IMPLANT AND DRAIN THE FLUID. THE CUSTOMER MENTIONED THAT WHAT HE WAS EXPECTING AS AN IMPLICATION FROM THE IFU WAS A CLEAR CAPSULE TO FORM AFTER THIS PERIOD AS A RESULT OF THE NEOCOLLAGEN FORMATION AND NEOVASCULARISATION. THIS DID NOT HAPPEN ACCORDING TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74498 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS 5798109-1789791

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other