BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 3640507 · Received February 21, 2014

    Report

    Report Number
    2032282-2014-00042
    Event Type
    Injury
    Date Received
    February 21, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER (B)(4) COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE OR LOT NUMBER WAS PROVIDED. A TREND WAS IDENTIFIED HOWEVER IT WAS CONCLUDED THAT NO CAPA IS WARRANTED AS THE ROOT CAUSE OF THE HERNIA RECURRENCE IS NOT DETERMINABLE FROM THE PROVIDED COMPLAINT INFORMATION. ADHESIONS ARE CONSIDERED TO BE A NORMAL HEALING RESPONSE AND IT IS NOT EVIDENT THAT THE USE OF VERITAS CONTRIBUTED TO THE FORMATION. PER SYNOVIS, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE ROOT CAUSE CANNOT BE DETERMINED THEREFORE FURTHER INVESTIGATION IS NOT POSSIBLE. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS A REPORT OF A RECURRENT PARAESOPHAGEAL HERNIA (PEH) AFTER SURGICAL HERNIA REPAIR USING THE VERITAS COLLAGEN MATRIX. WHILE RECURRENCES AFTER PEH SURGERY PARA HAVE A RELATIVELY HIGH RECURRENCE (12%¿42%; OELSCHLAGER ET AL., BIOLOGIC PROSTHESIS DURING LAPAROSCOPIC PEH REPAIR ANNALS OF SURGERY. VOLUME 244, NUMBER 4, OCTOBER 2006) WHEN TREATED VIA THE LAPAROSCOPIC APPROACH AND WITH PRIMARY REPAIR, WE CANNOT EXCLUDE A CONTRIBUTION OF VERITAS TO THE REPORTED ADVERSE EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO BAXTER SALES REPRESENTATIVE THAT A PATIENT EXPERIENCED DIAFERMALDNIA (VOICEMAIL WAS NOT CLEAR) REOCCURRENCE FOLLOWING IMPLANTATION OF VERITAS. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014: THE SURGEON CALLED TO REPORT THAT HE HAD TAKEN A (B)(6) FEMALE PATIENT BACK TO THE OPERATING ROOM FOLLOWING A PARAESOPHAGEAL HERNIA (PEH) REPAIR PROCEDURE WITH VERITAS COLLAGEN MATRIX IMPLANT REINFORCEMENT. THE PATIENT WAS RETURNED TO THE OPERATING ROOM DUE TO A RECURRENCE OF HER PEH HERNIA. THE SURGEON STATED HE OBSERVED ADHESIONS TO THE DIAPHRAGM, OMENTUM AND THE VERITAS COLLAGEN MATRIX. HE EXPLAINED THAT HE COULD VISUALIZE THE VERITAS MESH PRODUCT IN THE LOCATION OF THE REPAIR. HE DESCRIBED THAT HE TOOK DOWN THE ADHESIONS AND COMPLETED THE RECURRENT HERNIA REPAIR, AND IMPLANTED ANOTHER PIECE OF VERITAS COLLAGEN MATRIX TO REINFORCE THE NEW REPAIR. HE SAID THE PATIENT WAS IN GOOD CONDITION AND RECOVERING AS EXPECTED. HE SAID HE WILL MONITOR THE PATIENT GOING FORWARD FOR CONTINUED PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110953 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other