BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIFLO ULTRATHIN WITH UNITY CONTRUCTION

    MDR report key: 2720530 · Received August 27, 2012

    Report

    Report Number
    9612515-2012-00007
    Event Type
    Injury
    Date Received
    August 27, 2012
    Date of Event
    July 14, 2012
    Report Date
    August 31, 2012
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO GRAFT IS AVAILABLE FOR INSPECTION AND EVAL AS THE DEVICE HAS NOT BEEN EXPLANTED; THEREFORE NO TESTING OF THE DEVICE CAN TAKE PLACE. RESULTS: AS NO PRODUCT WAS AVAILABLE FOR INSPECTION AND EVAL A REVIEW OF THE MFG RECORDS ASSOCIATED WITH THE AFFECTED PRODUCT (MAXIFLO ULTRATHIN WITH UNITY CONSTRUCTION SERIAL NO (B)(4) LOT NO P3881/1B4306) WAS UNDERTAKEN; THIS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS. CONCLUSION: NO CONCLUSIONS CAN BE DRAWN. AS NO PRODUCT WAS RETURNED FOR INSPECTION AND EVAL, THE ROOT CAUSE OF THE REPORTED DEFECT COULD NOT BE ESTABLISHED. VASCUTEK HAVE WRITTEN TO THE DOCTOR WITH THE RESULTS OF THE MFG REVIEW. THE MAXIFLO ULTRATHIN WITH UNITY CONSTRUCTION WAS FIRST APPROVED IN (B)(4), AND IN THE USA IN 2004 (K041528).

    Description of Event or Problem · 1

    VASCUTEK WERE NOTIFIED OF THIS INCIDENT ON (B)(6) 2012 BY OUR (B)(6) SALES REP. AN ADVERSE EVENT FORM COMPLETED BY THE DOCTOR WAS SUBMITTED TO US. THE EVENT WAS DESCRIBED AS: THE PT WAS IMPLANTED WITH AN 8MM MAXIFLO ULTRATHIN UNITY GRAFT ON (B)(6) 2012. ON (B)(6) 2012, AN EMERGENCY OPERATION WAS REQUIRED DURING WHICH THE DOCTOR NOTICED A DEFECT ON THE BACK SIDE OF THE GRAFT, WHERE THE UNITY LOOPS HAD BEEN REMOVED DURING IMPLANT. DURING THE EMERGENCY OPERATION THE GRAFT WAS SHORTENED BY 2CM AND THE ANASTOMOSIS REDONE WITHOUT ANY FURTHER PROBLEMS. THE 2CM OF GRAFT REMOVED WAS NOT RETAINED FOR RETURN TO VASCUTEK. THE EVENT IS BEING REPORTED DUE TO RE-OPERATION 2 DAYS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIFLO ULTRATHIN WITH UNITY CONTRUCTION SYNTHETIC VASCULAR GRAFT DSY VASCUTEK LTD. T4008E P3881/1B4306

    Patients

    Seq Age Sex Outcome Treatment
    1 Other