BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 5884606 · Received August 17, 2016

    Report

    Report Number
    2021898-2016-00284
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    July 19, 2016
    Report Date
    July 19, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT ¿CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE.¿ IT IS ALSO SUGGESTED THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT AND MET THE REQUIREMENTS FOR REFLUX, AND PREIMPLANTATION TESTING. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR SIPHON AND PRESSURE FLOW TESTING. THERE WAS PROTEINACEOUS DEBRIS OBSERVED WITHIN THE INTERIOR AND EXTERIOR OF THE VALVE. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN RESULTING IN FLUID SIPHONING AND AFFECTING THE FLOW OF FLUID THROUGH THE VALVE. THE INSTRUCTIONS FOR USE (IFU) THAT ACCOMPANY THE DEVICE CAUTION THAT ¿SHUNT OBSTRUCTION MAY OCCUR IN ANY OF THE COMPONENTS OF THE SHUNT SYSTEM. THE SYSTEM MAY BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION, OR OTHER DEBRIS.¿ THE RETURNED VALVE ALSO DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A TEAR OBSERVED IN THE TOP OF THE DELTA CHAMBER. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE IFU THAT ACCOMPANY THE DEVICE CAUTION THAT ¿CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE.¿ IT IS ALSO SUGGESTED THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS FOUND TO BE LEAKING DURING PREOPERATIVE TESTING. ACCORDING TO THE REPORT, THE DOCTOR USED A NEW DEVICE TO COMPLETE THE SURGERY SUCCESSFULLY. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535277 STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY E09188

    Patients

    Seq Age Sex Outcome Treatment
    1