BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET

    MDR report key: 8611198 · Received May 15, 2019

    Report

    Report Number
    3002808486-2019-00616
    Event Type
    Death
    Date Received
    May 15, 2019
    Date of Event
    February 9, 2019
    Report Date
    July 10, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002213606
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404. REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K)/PMA: K172557. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON EVENT DESCRIPTION, PROVIDED AUTOPSY REPORT AND CLINICAL ASSESSMENT. IT HAS BEEN REPORTED THAT ON (B)(6) 2019, THE PATIENT RECEIVED HOSPITAL TREATMENT FOR DEEP VEIN THROMBOSIS (DVT). THE NEXT DAY, A COOK¿S GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET (IGTCFS-65-UNI) HAD BEEN PLACED IN THE PATIENT. ON (B)(6) 2019, THE PATIENT DIED AFTER THE FILTER HAD BEEN PLACED FOR 10 DAYS. AUTOPSY REPORT WAS PROVIDED FOR CLINICAL ASSESSMENT TO ASSIST COMPLAINT INVESTIGATION. NO CLINICAL IMAGING E.G. FROM IMPLANT PROCEDURE OR COMPLAINT PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. AS PER MEDICAL ADVISOR'S CLINICAL ASSESSMENT OF THE PROVIDED AUTOPSY REPORT; "THE AUTOPSY REPORT REVEALS THAT THE PATIENT HAD MYELITIS FOR MORE THAN MONTH, AN UNTREATED DVT FOR 1 MONTH PRIOR TO THE IVC FILTER PLACEMENT PROGRESSING TO INVOLVE THE RIGHT POPLITEAL VEIN 1 WEEK PRIOR TO THE IVC FILTER PLACEMENT. AT THE TIME OF DIAGNOSIS, THE PATIENT HAD NORMAL VITAL PARAMETERS. AFTER SUCCESSFUL AND UNEVENTFUL PLACEMENT OF THE GÜNTHER TULIP FILTER, ANTI-COAGULATION WAS INITIATED, THE LATTER INDICATIVE OF NO CONTRAINDICATION BEING PRESENT. KNOWN PRE-EXISTING CONDITIONS: MYELITIS, CORONARY ARTERY ATHEROSCLEROSIS AND LAD MYOCARDIAL BRIDGE THE MEDICAL RECORD DOES NOT HOLD ANY INFORMATION SUGGESTIVE OF RECURRENT PULMONARY EMBOLISM (PE), CONTRAINDICATIONS TO ANTICOAGULATION, FAILURE OF ANTICOAGULATION, MASSIVE PE OR CHRONIC, RECURRENT PE, AND AS SUCH THE PLACEMENT OF A GÜNTHER TULIP VENA CAVA FILTER IN THIS PATIENT SEEMS TO BE OUTSIDE THE INTENDED USE OF THE IFU. THE DEATH OF THIS PATIENT IS ASSESSED TO BE DIRECTLY RELATED TO THE GÜNTHER TULIP VENA CAVA FILTER BY PERFORATION OF THE INFERIOR VENA CAVA LEADING TO INTERNAL RETROPERITONEAL BLEEDING AND LETHAL HEMORRHAGIC SHOCK BASED ON THE CONCLUSION OF THE AUTOPSY REPORT. MYELITIS, CORONARY ATHEROSCLEROSIS AND LAD MYOCARDIAL BRIDGING ARE NOT CONSIDERED TO ACTIVELY CONTRIBUTE TO THE DEATH OF THIS PATIENT. THE PROVIDED DOCUMENTATION DOES NOT HOLD ANY INFORMATION SUGGESTIVE OF PE, RECURRENT PE, CONTRAINDICATION TO ANTICOAGULATION, FAILURE OF ANTICOAGULATION, MASSIVE PE OR CHRONIC PE AND THE PLACEMENT OF AN IVC FILTER IN THIS PATIENT WAS POSSIBLY OUTSIDE THE INTENDED USE OF THE DEVICE." PER THE PROVIDED AUTOPSY REPORT RESULTS AND FORENSIC PATHOLOGICAL EXAMINATION OF IMPORTANT ORGANS OF THE PATIENT, AND COMBINING WITH THE SUBMITTED CASE INFORMATION, MEDICAL RECORDS AND DEATH PROCESS, IT IS BELIEVED THAT THE PATIENT DIED OF HAEMORRHAGIC SHOCK BECAUSE OF RETROPERITONEAL HEMATOMA RESULTED FROM FILTER DISPLACEMENT ACCOMPANIED BY INFERIOR VENA CAVA PERFORATION AFTER INFERIOR VENA CAVA FILTER INSERTION ON THE BASIS OF CORONARY ARTERY ATHEROSCLEROSIS AND LAD MYOCARDIAL BRIDGE. PER MEDICAL ADVISOR'S CLINICAL ASSESSMENT FURTHER ADDITIONAL INFORMATION INCLUDING THE DIAMETER OF THE VENA CAVA INFERIOR PRIOR TO FILTER IMPLANTATION, IMAGING OF GÜNTHER TULIP FILTER AFTER IMPLANTATION IN ORDER TO ASSESS THE DEGREE OF MIGRATION, MEDICAL RECORDS INCLUDING BLOOD TESTS, INFORMATION OF CO-MORBIDITIES OR PRE-EXISTING CONDITIONS AND RATIONALE FOR NOT STARTING ANTICOAGULANT TREATMENT AT TIME OF DIAGNOSIS, COULD PROVIDE FURTHER UNDERSTANDING AS TO WHETHER THE PLACEMENT OF THE GÜNTHER TULIP FILTER WAS IN ACCORDANCE WITH THE IFU AND POSSIBLY PROVIDE UNDERSTANDING OF THE PATIENTS PRE-EXITING CONDITION. BASED ON THE INFORMATION PROVIDED, A CAUSE OF POTENTIAL DEVICE FAILURE LEADING TO THE AUTOPSY IDENTIFIED PATIENT DEATH OF "HAEMORRHAGIC SHOCK BECAUSE OF RETROPERITONEAL HEMATOMA RESULTED FROM FILTER DISPLACEMENT ACCOMPANIED BY INFERIOR VENA CAVA PERFORATION" CANNOT BE DETERMINED. IT IS CONFIRMED BASED ON AUTOPSY FINDINGS AND FURTHER MEDICAL ADVISORS CLINICAL ASSESSMENT CONCLUSION THAT "THE DEATH OF THIS PATIENT IS ASSESSED TO BE DIRECTLY RELATED TO THE GÜNTHER TULIP VENA CAVA FILTER BY PERFORATION OF THE INFERIOR VENA CAVA FILTER LEADING TO INTERNAL RETROPERITONEAL BLEEDING AND LETHAL HEMORRHAGIC SHOCK". IFU WARNS OF POTENTIAL ADVERSE EVENTS, INCLUDING BUT NOT LIMITED TO; ACUTE DAMAGE TO THE INFERIOR VENA CAVA, HEMORRHAGE, AND DEATH. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THE PATIENT RECEIVED HOSPITAL TREATMENT FOR DVT. THE NEXT DAY, A COOK¿S GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET (IGTCFS-65-UNI) HAD BEEN PLACED IN THE PATIENT. ON (B)(6) 2019, THE PATIENT DIED AFTER THE FILTER HAD BEEN PLACED FOR 10 DAYS. A HUGE HEMATOMA OF THE ABDOMINAL WALL (ABOUT 2000ML OF BLEEDING) WAS FOUND ON THE PATIENT. ON (B)(6) 2019, THE PATIENT DIED AFTER THE FILTER HAD BEEN PLACED FOR 10 DAYS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407079 GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G21360 E3806882 10827002213606

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death