BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA DP PEDIATRIC VALVE SYSTEM

    MDR report key: 6291194 · Received January 31, 2017

    Report

    Report Number
    9612007-2017-00005
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    September 17, 2014
    Report Date
    January 17, 2017
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K152897
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 3/06/2017. METHOD: -DHR REVIEW, -TREND ANALYSIS, -FAILURE ANALYSIS. THE DEVICE HISTORY RECORDS OF THE INTEGRA DP VALVE REF 902545, LOT 0182214, SN (B)(4) WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. THE BATCH WAS MANUFACTURED IN SEPTEMBER 2013 AND INCLUDED (B)(4) PRODUCTS. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH. THE REVIEW OF INTEGRA COMPLAINT TRACKING DATABASE SINCE 2014 FOR ALL INTEGRA DP VALVES REVEALS NO OTHER OVER DRAINAGE COMPLAINTS. (B)(4). NO TREND IS OBSERVED. THE VALVE WAS RECEIVED SOAKING IN A TRANSPARENT LIQUID AND CUT AT THE LEVEL OF THE VALVE CHAMBER (MISSING ANTECHAMBER) AND AT THE LEVEL OF THE DISTAL CATHETER. PATENCY TEST (AIR/WATER ASPIRATION) SHOWED THE VALVE WAS BLOCKED. INSPECTION UNDER MAGNIFICATION SHOWED TRANSLUCENT CRYSTALS AT THE INLET SIDE OF THE VALVE MECHANISM, LIKELY CRYSTAL SALTS RELATED TO THE SOAKING LIQUID (SALINE) THE VALVE WAS SENT IN. THE VALVE WAS CONNECTED TO THE PRESSURE/FLOW TEST EQUIPMENT AND CONFIRMED AN OBSTRUCTION; A FLUSH WITH WARM WATER DISSOLVED THE CRYSTAL SALTS. THE VALVE WAS RE-TESTED AND FOUND WITHIN SPECIFICATIONS (40-80 MMHG). CONCLUSION: THE COMPLAINT IS VERIFIED, THE RECEIVED VALVE WAS BLOCKED. THE MOST LIKELY REASON OF THIS BLOCKAGE IS THE PRESENCE OF CRYSTAL SALTS, LINKED TO THE SOLUTION (SALINE) USED TO SHIP THE VALVE TO INTEGRA. THE MANUFACTURING PROCESS OF THE VALVES INCLUDES ONLY TESTS WITH AIR. NEITHER WATER NOR SALINE IS USED. THE FINAL MANUFACTURING STEP INCLUDES A PRESSURE/FLOW TEST AND THE VALVE CAT#902545, SERIAL (B)(4) WAS TESTED WITHIN PRESSURE/FLOW SPECIFICATIONS, AS SHOWN ON THE DEVICE HISTORY RECORDS. IT IS ALSO POSSIBLE THAT THE VALVE MECHANISM WAS BLOCKED BY RESIDUES (PROTEINACEOUS, PATIENT-RELATED). VALVE OBSTRUCTION IS KNOWN TO BE CORRELATED TO SHUNT SYSTEM OVER DRAINAGE; OVERDRAINAGE MAY NARROW THE VENTRICLES, AND THIS CAN BLOCK THE VENTRICULAR CATHETER, THEN RESIDUES CAN MOVE ALONG THE SHUNT AND BLOCK THE VALVE MECHANISM. A SMALL RESIDUE BLOCKING THE VALVE MECHANISM COULD BE REMOVED BY THE VALVE FLUSH. THE VALVE (LOW PRESSURE VALVE) WAS IMPLANTED FOR 2.5 YEARS. GIVEN THE ABSENCE OF REPORTED OVER DRAINAGE WITH INTEGRA DP VALVES SINCE JANUARY 2013 , GIVEN THE RESULTS OF THE INVESTIGATION AND GIVEN THE EXISTING MANUFACTURING PROCESSES AND CONTROLS, NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED.

    Description of Event or Problem · 1

    THERE WAS A REPORT OF OVER DRAINAGE WITH INTEGRA DP VALVE. THE VALVE WAS IMPLANTED 2.5 YEARS AGO ON 17 SEP 2014 DUE TO POSTHEMORRHAGIC HYDROCEPHALUS. THE ISSUE WAS DETECTED WITH CLINIC ASPECT, ON IRM THE VENTRICLES WERE NARROW. THE VALVE WAS THEN EXPLANTED AND REPLACED BY ANOTHER "MIETHKE PRO GAV 2.0". THE PATIENT'S CONDITION GOT BETTER AFTER IMPLANTATION OF THE REPLACEMENT VALVE AND HAD GOOD RECOVERY. THE CEREBROSPINAL FLUID (CSF) PROTEIN LEVEL HAS NOT BEEN CHECKED AND NO PARTICULE HAS BEEN FOUND ON THE DEFECTIVE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73877 INTEGRA DP PEDIATRIC VALVE SYSTEM DP VALVE JXG INTEGRA NEUROSCICENCS IMPLANTS SA 105643

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention