BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 3586247 · Received January 21, 2014

    Report

    Report Number
    2032282-2014-00015
    Event Type
    Injury
    Date Received
    January 21, 2014
    Date of Event
    January 10, 2005
    Report Date
    January 7, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: A PUBLICATION ON THE USE OF VERITAS COLLAGEN MATRIX IN COMPLEX ABDOMINAL RECONSTRUCTION PROCEDURES IN WHICH PROSTHETIC MESHES HAD FAILED OR WAS CONTRAINDICATED IS REPORTING THE COMPLICATIONS FOLLOWING THIS TYPE OF COMPLEX SURGERY. THE SMALL CLINICAL SERIES OF 26 PATIENTS REFERS TO FIVE CASES OF HERNIA RECURRENCE, ONE ALLOGRAFT LOST, ONE SEROMA AND ONE INTRA-ABDOMINAL ABSCESS. HERNIA RECURRENCE IN SUCH COMPLEX PROCEDURES IS REPORTED TO BE AS HIGH AS 54%, WHILE IN THIS SMALL, NON-REPRESENTATIVE SERIES THE RECURRENCE RATE HAS BEEN DETERMINED TO BE 19%. WHILE COMPLEX PATIENT-, DISEASE- AND PROCEDURE-RELATED FACTORS MIGHT PLAY A SIGNIFICANT ROLE IN THE HERNIA RECURRENCE CAUSALITY, WE CANNOT EXCLUDE THAT VERITAS COLLAGEN MATRIX HAS CAUSED OR CONTRIBUTED TO THE REPORTED OUTCOMES. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE OR LOT NUMBER WAS PROVIDED. NO TREND WAS IDENTIFIED. PER SYNOVIS, THE ROOT CAUSE OF THE HERNIA RECURRENCE IS NOT DETERMINABLE. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A LITERATURE (LIMPERT, JONATHAN N. ET AL. ¿REPAIR OF ABDOMINAL WALL DEFECTS WITH BOVINE PERICARDIUM.¿ THE AMERICAN JOURNAL OF SURGERY (2009) DOI:10.1016. 14 JANUARY 2009.) THAT A TOTAL OF EIGHT (8) PATIENTS EXPERIENCED COMPLICATIONS AFTER ABDOMINAL SURGERY IN WHICH VERITAS WAS USED. FIVE (5) PATIENTS EXPERIENCED HERNIA RECURRENCE. ONE (1) EXPERIENCED A MINOR COMPLICATION OF SEROMA. ONE (1) PATIENT WITH A RECURRENT HERNIA AND LOSS THE ALLOGRAFT. ONE (1) PATIENT EXPERIENCED POST-OPERATIVE INTRA-ABDOMINAL PSEUDOMONAS ABSCESS. THIS REPORT REFLECTS ONE OF THE FIVE PATIENTS WHO EXPERIENCED HERNIA RECURRENCE. ABSTRACT: BACKGROUND - VENTRAL HERNIA REPAIR WITH PROSTHETIC MESH HAS RECURRENCE RATES UP TO 54% AND IS CONTRAINDICATED IN THE SETTING OF INFECTION. THE AIM OF THIS STUDY WAS TO PROVIDE OUR EXPERIENCE WITH ACELLULAR BOVINE PERICARDIUM (VERITAS COLLAGEN MATRIX; SYNOVIS LIFE TECHNOLOGIES, INC., (B)(4)) IN COMPLEX ABDOMINAL WALL RECONSTRUCTION WHERE PROSTHETIC MESH HAD FAILED OR WAS CONTRAINDICATED. BETWEEN 2005 AND 2008, A RETROSPECTIVE REVIEW OF A SINGLE GENERAL SURGEON'S PRACTICE IDENTIFIED PATIENTS RECONSTRUCTED WITH ACELLULAR BOVINE PERICARDIUM. THIRTY PRIMARY OR RECURRENT VENTRAL HERNIAS WERE TREATED IN 26 PATIENTS. ALL PATIENTS PRESENTED WITH EITHER CONTAMINATED WOUNDS OR FAILURE OF A PROSTHETIC MESH MATERIAL. RESULTS - HERNIA SIZE RANGED FROM 20 CM² TO 600 CM² (MEAN III CM²). SEVEN PATIENTS HAD PREVIOUS HERNIA REPAIR WITH PROSTHETIC MESH, AND 16 PATIENTS HAD ONGOING INFECTION OR GROSS CONTAMINATION AT THE TIME OF REPAIR. THE MEAN FOLLOW-UP WAS 22 MONTHS. THE HERNIA RECURRENCE RATE IN OUR SERIES WAS 19% WITH NO FISTULA DEVELOPMENT. CONCLUSIONS - ACELLULAR BOVINE PERICARDIUM'S HIGH STRENGTH, MINIMAL INFECTION RATE, AND LOW COST ALLOW ITS USE IN THE RECONSTRUCTION OF COMPLEX ABDOMINAL WALL DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47153 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other