BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PLUS ADHESION BARRIER MATRIX 1X1, 5 PACK

    MDR report key: 5147429 · Received October 14, 2015

    Report

    Report Number
    1121308-2015-00021
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 18, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K032693
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 10/30/2015. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY REVIEW. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE UNIT WAS NOT RETURNED FOR EVALUATION SINCE THE UNIT WAS IMPLANTED IN THE PATIENT. FIVE (5) RETAIN SAMPLES OF FG LOT 1141352 WERE VISUALLY EVALUATED FOR PRODUCT AND PACKAGING APPEARANCE TO CONFIRM NO DETERIORATION. THE FIVE (5) UNITS MET PRODUCT AND PACKAGING SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) OF THE FINISHED GOOD LOT # 1141352 WAS REVIEWED. THE MANUFACTURING PROCESS OF CATALOG DP5011I INCLUDES CUTTING & INSPECTION, QA INSPECTION, TRAYS CLEANING, TYVEK LIDS STAMPING AND INSPECTION, PACK PRODUCT, QA INSPECT PACKED PRODUCT, BULK BOXING, BULK BOXING INSPECTION, STERILIZATION (AT OUTSIDE SOURCE), PIGGYBACK AND OUTER BOX LABELS PRINTING, LABELS INSPECTION, LABELS APPLICATION AND BOXING, FINAL INSPECTION, AND PRODUCT RELEASE. BASED ON THE DEVICE HISTORY RECORD (DHR) OF 1141352, NO ANOMALIES WERE OBSERVED DURING THE MANUFACTURING AND PACKAGING PROCESS. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED REGARDING FG LOT 1141352. ACCORDING TO THE DEVICE HISTORY RECORD (DHR) OF FG LOT 1141352, (B)(4) UNITS WERE RELEASED FOR DISTRIBUTION. AFTER REVIEWING THE INTEGRA LIFESCIENCES PR FACILITY COMPLAINT SYSTEM SINCE 2013, ONLY THIS COMPLAINT HAS BEEN REPORTED REGARDING TO DURAGEN PLUS 'CSF LEAKAGE'. APPROXIMATELY (B)(4) UNITS OF DURAGEN PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES SINCE 2013 UNTIL 09/24/15, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). CONCLUSION: ALTHOUGH NO RETURN UNIT WAS RECEIVE FOR EVALUATION, BASED ON MEDICAL AFFAIRS ASSESSMENT, THE REPORTED CONDITION OF 'CSF LEAKAGE' WAS NOT CONFIRMED TO BE RELATED TO DURAGEN PLUS PRODUCT. ACCORDING TO THE MEDICAL INSIGHT, EVEN THOUGH THE DURASEAL XACT WAS NOT USED CORRECTLY, THE MOST PROBABLE CAUSE OF THE REPORTED CONDITION IS RELATED TO THE DRAIN TECHNIQUE USED IN THE PROCEDURE. APPROPRIATE USE OF A DRAIN IS TECHNIQUE DEPENDENT AND IN THIS CASE, THE DRAIN VERY LIKELY CONTRIBUTED TO THE LARGE VOLUME OF THE CSF LEAK THAT IN TURN CAUSED THE CEREBRAL BLEED. THE CEREBRAL BLEED IS A RESULT OF LOSS OF CSF VOLUME IN A SHORT PERIOD OF TIME, THE INTRACRANIAL PRESSURE FALLS RAPIDLY AND THE BLOOD VESSELS IN THE BRAIN BURST UNDER NORMAL BLOOD PRESSURE WHEN THERE IS NO EXTERNAL RESISTANCE FROM THE CSF PRESSURE.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS. IT WAS REPORTED THAT DURASEAL XACT USED ON (B)(6) 2015 AND THERE WAS A LEAK ON (B)(6) 2015. ADDITIONAL INFORMATION WAS RECEIVED ON 23SEP2015 WITH THE FOLLOWING: THE PATIENT HAD A REMOVAL OF A NEUROFIBROMA AND HAD DURAGEN PLUS AND DURASEAL XACT USED FOR DURAL REPAIR. A SUCTION DRAIN WAS SITED. VERY SOON POST-OPERATIVELY, THE PATIENT HAD A CEREBRAL BLEED AND HAD A CEREBROSPINAL FLUID (CSF) LEAKAGE EVIDENT BY THE VOLUME IN THE DRAIN. THE PATIENT BECAME VERY "UNWELL" AND WAS TRANSFERRED TO THE NEAREST HOSPITAL. THE EVENT DID NOT LEAD TO AN INCREASE OF SURGERY TIME. NO PRODUCT WILL BE RETURNED BECAUSE IT IS STILL IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2015 WITH THE FOLLOWING: THE PATIENT DID HAVE TWO FURTHER OPERATIONS AFTER THE NEUROFIBROMAS REMOVAL BUT NEITHER OF THE OPERATIONS THE PHYSICIAN BELIEVED WERE DUE TO THE CSF LEAK BUT THE CEREBRAL BLEED THE PATIENT SUSTAINED POST OPERATIVELY. THE PATIENT IS IMPROVING. THE PHYSICIAN EXPLAINED HIS TECHNIQUE OF USING DURAGEN AND DURASEAL: HE APPLIED THE DURAGEN PLUS CORRECTLY BUT IT APPEARED HE DIDN'T HAVE THE END TIP ON THE Y CONNECTOR OF THE DURASEAL FOR WHATEVER REASON AS HE DID NOT GET A SPRAY EFFECT. HE ALSO SAID THAT HE COVERED ONLY THE PERIMETER (OUTER EDGE) OF THE DURAGEN PLUS WITH DURASEAL XACT. A DRAIN WAS PLACED AND THEN CLOSED. IT WASN'T A SUCTION DRAIN BUT A GRAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679133 DURAGEN PLUS ADHESION BARRIER MATRIX 1X1, 5 PACK N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1141352

    Patients

    Seq Age Sex Outcome Treatment
    1 Other