BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3

    MDR report key: 5251328 · Received November 25, 2015

    Report

    Report Number
    1121308-2015-00027
    Event Type
    Death
    Date Received
    November 25, 2015
    Date of Event
    October 15, 2015
    Report Date
    November 16, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K043427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL DEVICE: DURASEAL ((B)(4)), LOT NO: NEO372X; EXPIRATION DATE:11/30/2016.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 20APR2016. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. THE ONE (1) FINISHED GOOD (FG) RETAIN SAMPLE FOR THE REPORTED LOT NO. (1151696) WAS VISUALLY INSPECTED FOR SIGNS OF DETERIORATION WITHOUT REMOVAL FROM ITS SEALED, STERILE PACKAGING. NO VISIBLE SIGNS OF DETERIORATION OR OTHER VISUAL ANOMALIES WERE NOTED. ACCORDING TO THE DHR REVIEW CONDUCTED FOR FG LOT 1151696 THERE IS NO INDICATION THAT THE PRODUCTION PROCESS OF THIS LOT CONTRIBUTED TO THE COMPLAINT EVENT. NO ANOMALIES WERE REPORTED DURING THE MANUFACTURING AND PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. AFTER REVIEWING THE COMPLAINT SYSTEM SINCE 2013, ONLY THIS COMPLAINT RELATED TO ¿FUNGAL INFECTION¿ HAS BEEN REPORTED IN DURAGEN SUTURABLE FAMILY AT INTEGRA LIFESCIENCES PR FACILITY. (B)(4). GIVEN THAT COMPLAINT UNIT WAS NOT RETURNED FOR EVALUATION, IT IS NOT POSSIBLE TO ASCERTAIN ANY CAUSE RELATIONSHIP TO THE COMPLAINT. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS WERE IDENTIFIED BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD (DHR), CAPAS, NCRS HISTORY AND RETAIN SAMPLES EVALUATION. THE MEDICAL ASSESSMENT STATES THAT MENINGITIS IS AN INHERENT RISK OF NEUROSURGERY AND THAT MULTIPLE DEVICES IN THE OR AND POST-OPERATIVE ENVIRONMENTS MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THIS CASE OF MENINGITIS. PATIENT COMORBIDITIES, SUCH AS IMMUNOSUPPRESSION MAY HAVE BEEN CONTRIBUTING FACTORS. THE INCIDENCE OF MENINGITIS COMPLAINTS OF ANY ETIOLOGY FOR DURAGEN IS LOW (<0.0015%) AND RATES OF MENINGITIS REPORTED FOR DURAGEN FROM 2009 TO 2015 HAVE NOT BEEN INCREASING. NO OTHER FUNGAL INFECTIONS HAVE BEEN REPORTED ACROSS DURAGEN OR OTHER INTEGRA COLLAGEN PRODUCT LINES. AN INDEPENDENT, BOARD CERTIFIED INFECTIOUS DISEASE DOCTOR, DR. (B)(6) MD WAS ASKED TO REVIEW THE PATIENT CHART AND ASSOCIATED COMPLAINT INFORMATION. DR. (B)(6) COMPLETED MEDICAL SCHOOL AND TRAINING IN INFECTIOUS DISEASES AT (B)(6) AND POST DOC TRAINING AT (B)(6). HE IS AN INVITED REVIEWER ON THE FOLLOWING JOURNALS: AMERICAN JOURNAL OF INFECTION CONTROL, ARCHIVES OF INTERNAL MEDICINE AND CLINICAL INFECTIOUS DISEASES. DR. (B)(6) CONCLUDED THAT, IN THE ABSENCE OF A SECOND CASE, THE PRESENCE OF THIS FUNGUS COULD BE LINKED TO THE PROCEDURE, DEVICE, GEOGRAPHY, OR TIME AND THAT THIS REPRESENTS AN ISOLATED, RARE, SPONTANEOUS EVENT RATHER THAN A PATTERN OF CONCERN.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER INITIALLY REPORTED FOR THE CONCOMITANT MEDICAL DEVICE (DURASEAL) WAS NEO372X . HOWEVER, AS PER MEDTRONIC, THE LOT NUMBER SHOULD BE N5E0372X.. AN INDEPENDENT 3RD PARTY PHYSICIAN CONSULTANT HAS BEEN CONTRACTED TO REVIEW THE PATIENT'S MEDICAL RECORDS AND PROVIDE AN ASSESSMENT. A SUMMARY OF THAT ASSESSMENT IS AS FOLLOWS: 'THE PATIENT IS A (B)(6) WOMAN WITH CHIARI 1 WITH NO SIGNIFICANT PAST HISTORY. THE PATIENT UNDERWENT ELECTIVE CRANIOTOMY AND DECOMPRESSION ON (B)(6) 2015. DURAGEN WAS USED TO SEAL THE DURAL DEFECT. THE PATIENT RECEIVED PERI-OPERATIVE STEROIDS AND PROPHYLACTIC ANTIBIOTIC THERAPY. SHE WAS DISCHARGED ON (B)(6) 2015. THE PATIENT HAD PERSISTENT UNREMITTING HEADACHES AND NAUSEA WHICH PROMPTED READMISSION ON (B)(6) 2015 AT WHICH TIME SHE WAS GIVEN HIGH DOSE OF DECADRON. HER HEADACHE IMPROVED. SHE WAS THEN READMITTED ON (B)(6) 2015 WITH SEVERE HEADACHE AND RETURNED TO THE OPERATING ROOM ON (B)(6) 2015. THE DURAGEN GRAFT WAS REMOVED. DURING THE PROCEDURE, COVERING OF THE GRAFT WAS DESCRIBED AS INFLAMMATORY TISSUE WAS NOTED. CEREBROSPINAL FLUID (CSF) WAS POSITIVE FOR MOLD. THE GRAFT HAD ACUTE INFLAMMATORY CELLS AND SPECIAL STAINS REVEALED A MOLD NOT SPECIFICALLY IDENTIFIED. THE PATIENT DIED ON (B)(6) 2015'. 'SURGICAL PATHOLOGY REPORT: SPECIMEN: DURAL GRAFT (COLLECTED (B)(6) 2015, RESULT ON (B)(6) 2015) -GROSS DESCRIPTION: THE SPECIMEN IS DESIGNATED ¿DURAL GRAFT¿ AND CONSISTS OF MULTIPLE FLAT FRAGMENTS OF PROSTHETIC SYNTHETIC MATERIAL AS WELL AS ONE SMALL SUTURE. THE FRAGMENTS AGGREGATE TO 3.3 X 3 X 0.1CM. ATTACHED TO THE LARGEST FRAGMENT IS A SMALL AMOUNT OF TAN-PINK POSSIBLE TISSUE MEASURING 1.5 X 0.6 X LESS THAN 0.1CM. THIS POSSIBLE TISSUE IS SUBMITTED AS ¿1A¿. THE REMAINING MATERIAL IS SUBMITTED FOR GROSS ONLY DIAGNOSIS. -MICROSCOPIC DESCRIPTION: MICROSCOPICALLY EXAMINED BUT NOT DICTATED¿ 'CONCLUSIONS: 1. THE PATIENT DIED FROM PROGRESSIVE INTRACRANIAL HYPERTENSION 2. SHE HAD AN INFECTION OF THE GRAFT WITH A MOLD AND THE SAME MOLD CAUSED MENINGITIS 3. THE MENINGITIS CONTRIBUTED TO AND OR WAS THE PRIMARY CAUSE OF THE PROGRESSIVE INTRACRANIAL HYPERTENSION. 4. THE MOLD WAS LIKELY INTRODUCED AT THE TIME OF THE FIRST SURGERY. 5. THE HIGH DOSE STEROIDS ON THE SECOND ADMISSION CONTRIBUTED TO MORE RAPID GROWTH OF THE MOLD BY SUPPRESSION OF THE HOST CELLULAR IMMUNITY. 6. THE SURGICAL PROCEDURE AND GRAFT AT THE TIME OF FIRST PROCEDURE CREATED AN INFLAMMATORY RESPONSE THAT CREATED AN ENVIRONMENT THAT PREDISPOSES TO THE ESTABLISHMENT OF INFECTION. 7. THIS MOLD HAS NOT BEEN REPORTED TO CAUSE POST-OPERATIVE INTRACRANIAL INFECTIONS. 8. THE MOLD IS RELATIVELY COMMON IN THE ENVIRONMENT BUT HAS NOT BEEN REPORTED TO CAUSE INTRA-CRANIAL INFECTIONS POST OPERATIVELY OTHERWISE. 9. THIS IS AN UNUSUAL INFECTION THAT APPEARS TO BE A SINGLE ISOLATED EVENT AS THERE ARE NO OTHER CASES IDENTIFIED DESPITE HEIGHTENED DUE DILIGENCE THAT CAN BE LINKED EITHER TEMPORALLY OR GEOGRAPHICALLY. 10. IN THE ABSENCE OF A SECOND CASE OF THIS FUNGUS THAT COULD LINKED BY PROCEDURE, DEVICE, GEOGRAPHY, OR TIME THIS REPRESENTS AN ISOLATED, RARE, SPONTANEOUS EVENT RATHER THAN A PATTERN OF CONCERN. 11. THE SOURCE OF THE MOLD IS UNKNOWN'.

    Description of Event or Problem · 1

    MAUDE REPORT (MW5057848). ON (B)(6) 2015, THE PATIENT UNDERWENT A SUBOCCIPITAL CRANIECTOMY FOR CHIARI I MALFORMATION. A SMALL PIECE OF SUTURABLE DURAGEN WAS SEWN IN AS A DIAMOND SHAPED PATCH ALONG WITH THE DURA. AFTER DISCHARGE HOME, SHE HAS PROGRESSIVELY WORSENING HEADACHES AND PAIN AS WELL AS NAUSEA AND VOMITING. NO FEVER AND NO DRAINAGE FROM HER INCISION OR OTHER SIGNS OF INFECTION. SHE REPORTED HER EYES WERE SENSITIVE TO LIGHT. POSTOPERATIVELY, THE PATIENT CONTINUED TO HAVE RECALCITRANT HEADACHES, NAUSEA, AND VOMITING. SHE HAS SOME MILD HYDROCEPHALUS POSTOPERATIVELY. SHE WAS ADMITTED AS AN INPATIENT ON (B)(6) 2015 WITH COMPLAINTS OF HEADACHE, NAUSEA AND VOMITING, WHICH DRAMATICALLY IMPROVED WITH INTRAVENOUS (IV) STEROIDS. SHE WAS DISCHARGED HOME AFTER TWO DAYS. SHE RETURNED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2015 WITH SYMPTOMS. HER POSTOPERATIVE WOUND WAS CLEAR AND DRY AND INTACT WITH NO EVIDENCE OF INFECTION. SHE WAS ADMITTED FOR WORK UP, WHICH INCLUDED A LUMBAR PUNCTURE AND INFECTIOUS DISEASE CONSULT. SHE RECEIVED ANTIBIOTICS INTRAVENOUSLY AND WAS DISCHARGED HOME ON (B)(6) 2015. SHE RETURNED TO THE ER ON (B)(6) 2015 AT 2155 AND READMITTED TO THE HOSPITAL. ON (B)(6) 2015, SHE UNDERWENT A REVISION OF CHIARI MALFORMATION AND REMOVAL OF THE DURAL GRAFT, TONSILLECTOMY, AND HARVESTING OF PERICRANIAL GRAFT. THERE WAS INFLAMMATORY TISSUE ALL AROUND THE DURAL GRAFT. POSTERIOR FOSSA FLUID WAS COLLECTED AND WAS CLOUDY BUT NOT PURULENT. ON (B)(6) 2015, THERE WAS A RARE MOLD IN THE SURGICAL CULTURE. ON (B)(6) 2015 AT 2035, THE PATIENT EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782209 DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3 N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1151696

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death