BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 3151440 · Received June 7, 2013

    Report

    Report Number
    9616099-2013-00352
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    August 1, 2006
    Report Date
    May 13, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPEAT HEMOGLOBIN WAS 9.3 G/DL, PLATELETS 398, PT 13.5 S, AND THE PTT WAS 30.5 S. HER HEMODYNAMICS STABILIZED AFTER RESUSCITATION, AS DID HER HEMOGLOBIN AND COAGULATION PROFILE WITH NO FURTHER VOLUME REQUIREMENT. VASCULAR SURGERY WAS CONSULTED AND AGREED WITH OUR CONSERVATIVE MANAGEMENT CONSISTING OF STRICT BED REST,AND A NON-OPERATIVE ¿¿WATCH AND SEE¿¿ APPROACH. REPEAT ABDOMINAL X-RAY SHOWED NO VCF MIGRATION. HYPERCOAGULATION STUDIES OF PROTEIN C, PROTEIN S, ANTI-THROMBIN III, LUPUS ANTICOAGULANT SHOWED NORMAL RESULTS. AXIAL CT SCANS OF BOTH THE ABDOMEN AND PELVIS PERFORMED, IDENTIFIED AN IVC FILTER IN AN UNCHANGED POSITION AND A LARGE RETROPERITONEAL HEMATOMA, MEASURING 12.4 CM _ 7.3 CM THAT WAS STABLE IN SIZE SINCE THE PRIOR STUDY. THERE WAS INTERVAL DECREASE IN THE DEGREE OF HEMOPERITONEUM. CT ANGIOGRAM DEMONSTRATED RESIDUAL THROMBOSIS OF THE LEFT EXTERNAL ILIAC, COMMON AND PROXIMAL SUPERFICIAL FEMORAL VEINS. REPEAT CT DID NOT DEMONSTRATE ANY SIGNS OF PSEUDOANEURYSM OR ACUTE BLEEDING. LOW MOLECULAR WEIGHT HEPARIN (DALTEPARIN) PROPHYLAXIS WAS RESUMED AT A DOSE OF 2500 UNITS SUBCUTANEOUS EVERY 12 HOURS. HER SUBSEQUENT RECOVERY WAS UNEVENTFUL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. LITERATURE ARTICLE BRZEZINSKI, M, SCHMIDT, U, AND FITZSIMONS (2006, JANUARY 31). ACUTE AND MASSIVE HEMORRHAGE DUE TO CAVA PERFORATION BY AN INFERIOR VENA CAVA FILTER ¿ ABSOLUTE INDICATION FOR SURGERY BURNS, 32, 640-643.

    Additional Manufacturer Narrative · 1

    THE EVENT REFLECTS THE VENA CAVA INJURY. COMPLAINT CONCLUSION: BRZEZINSKI, M, SCHMIDT, U, AND FITZSIMONS (2006, JANUARY 31). ACUTE AND MASSIVE HEMORRHAGE DUE TO CAVA PERFORATION BY AN INFERIOR VENA CAVA FILTER ¿ ABSOLUTE INDICATION FOR SURGERY? BURNS, 32, 640-643. A PATIENT DEVELOPED AN ACUTE AND MASSIVE INTRAPERITONEAL AND RETROPERITONEAL HEMORRHAGE DUE TO CAVAL PERFORATION BY AN UNKNOWN TRAPEASE VENA CAVA FILTER. THE PATIENT WAS MANAGED CONSERVATIVELY AS VASCULAR SURGERY WAS ABSOLUTE. INITIALLY, THE PATIENT DEVELOPED A LARGE LEFT COMMON FEMORAL VEIN DEEP VENOUS THROMBOSIS (DVT) DESPITE DVT PROPHYLAXIS. THE LARGE SIZE OF THE THROMBUS AND THE ANTICIPATED PROLONGED RELATIVE IMMOBILIZATION NECESSITATED THE PLACEMENT OF IVC. INTRAVENOUS ACCESS WAS OBTAINED THROUGH A RIGHT TRANSFEMORAL VENOUS ANTEROGRADE APPROACH. THE CONTRAST DYE DEMONSTRATED DVT INVOLVING BOTH ILIAC VEINS AND THE DISTAL IVC. AFTER POSITIONING THE FILTER KIT SHEET INTO THE INFRARENAL VENA CAVA, THE VENOGRAM DEMONSTRATED A PATENT INFRARENAL IVC. THE RENAL VEINS WERE THEN IDENTIFIED, AND A TRAPEASETM IVC FILTER WAS DEPLOYED JUST BELOW THE RENAL VEIN. REPEAT INFERIOR VENA CAVOGRAM SHOWED THE VENA CAVA FILTER IN CORRECT POSITION. SIX HOURS AFTER THE PLACEMENT OF THE VENA CAVA FILTER, HEMOGLOBIN DROP FROM 9.3 DOWN TO 8.1 G/DL WAS NOTED. SHE WAS GIVEN A TRANSFUSION OF TWO UNITS OF BLOOD. OVER THE SUBSEQUENT 24 HOURS. SHE BECAME INCREASING UNSTABLE. COMPUTED TOMOGRAPHY (CT) SHOWED EVIDENCE OF HEMOPERITONEUM AND A MASSIVE RETROPERITONEAL HEMATOMA MEASURING 13.2 CM _ 8.3 CM ADJACENT TO THE INFERIOR VENA CAVA. THERE WAS THROMBUS WITHIN THE RIGHT COMMON AND EXTERNAL ILIAC VEINS, LEFT EXTERNAL ILIAC VEINS, AND LEFT COMMON FEMORAL VEIN. A VENOGRAM SHOWED THAT THE VENOUS FILTER WAS UNCHANGED IN POSITION. THE REPEAT HEMOGLOBIN DURING THE RESUSCITATION WAS 4.7 G/DL, AND THE PATIENT RECEIVED FIVE UNITS OF PACKED RED BLOOD CELLS (PRBC) AND TWO UNITS OF FRESH FROZEN PLASMA (FFP). LOW MOLECULAR WEIGHT HEPARIN WAS DISCONTINUED. REPEAT HEMOGLOBIN WAS 9.3 G/DL, PLATELETS 398, PT 13.5 S, AND THE PTT WAS 30.5 S. HER HEMODYNAMICS STABILIZED AFTER RESUSCITATION, AS DID HER HEMOGLOBIN AND COAGULATION PROFILE WITH NO FURTHER VOLUME REQUIREMENT. VASCULAR SURGERY WAS CONSULTED AND AGREED WITH OUR CONSERVATIVE MANAGEMENT CONSISTING OF STRICT BED REST,AND A NON-OPERATIVE ¿¿WATCH AND SEE¿¿ APPROACH. REPEAT ABDOMINAL X-RAY SHOWED NO VCF MIGRATION. HYPERCOAGULATION STUDIES OF PROTEIN C, PROTEIN S, ANTI-THROMBIN III, LUPUS ANTICOAGULANT SHOWED NORMAL RESULTS. AXIAL CT SCANS OF BOTH THE ABDOMEN AND PELVIS PERFORMED, IDENTIFIED AN IVC FILTER IN AN UNCHANGED POSITION AND A LARGE RETROPERITONEAL HEMATOMA, MEASURING 12.4 CM _ 7.3 CM THAT WAS STABLE IN SIZE SINCE THE PRIOR STUDY. THERE WAS INTERVAL DECREASE IN THE DEGREE OF HEMOPERITONEUM. CT ANGIOGRAM DEMONSTRATED RESIDUAL THROMBOSIS OF THE LEFT EXTERNAL ILIAC, COMMON AND PROXIMAL SUPERFICIAL FEMORAL VEINS. REPEAT CT DID NOT DEMONSTRATE ANY SIGNS OF PSEUDOANEURYSM OR ACUTE BLEEDING. LOW MOLECULAR WEIGHT HEPARIN (DALTEPARIN) PROPHYLAXIS WAS RESUMED AT A DOSE OF 2500 UNITS SUBCUTANEOUS EVERY 12 HOURS. HER SUBSEQUENT RECOVERY WAS UNEVENTFUL. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE IFU LISTS PERFORATION OF THE VESSEL WALL, INTIMAL TEAR, FILTER AND THROMBUS FORMATION AS POSSIBLE PROCEDURE COMPLICATIONS. BASED ON THE LIMITED PROCEDURAL INFORMATION PROVIDED REGARDING FILTER PLACEMENT, IT IS NOT POSSIBLE TO DETERMINE WHAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS REPORTED. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN A LITERATURE PUBLICATION, A PATIENT DEVELOPED AN ACUTE AND MASSIVE INTRAPERITONEAL AND RETROPERITONEAL HEMORRHAGE DUE TO CAVAL PERFORATION BY AN UNKNOWN TRAPEASE VENA CAVA FILTER. THE PATIENT WAS MANAGED CONSERVATIVELY AS VASCULAR SURGERY WAS ABSOLUTE. INITIALLY, THE PATIENT DEVELOPED A LARGE LEFT COMMON FEMORAL VEIN DEEP VENOUS THROMBOSIS (DVT) DESPITE DVT PROPHYLAXIS. THE LARGE SIZE OF THE THROMBUS AND THE ANTICIPATED PROLONGED RELATIVE IMMOBILIZATION NECESSITATED THE PLACEMENT OF IVC. INTRAVENOUS ACCESS WAS OBTAINED THROUGH A RIGHT TRANSFEMORAL VENOUS ANTEROGRADE APPROACH. THE CONTRAST DYE DEMONSTRATED DVT INVOLVING BOTH ILIAC VEINS AND THE DISTAL IVC. AFTER POSITIONING THE FILTER KIT SHEET INTO THE INFRARENAL VENA CAVA, THE VENOGRAM DEMONSTRATED A PATENT INFRARENAL IVC. THE RENAL VEINS WERE THEN IDENTIFIED, AND A TRAPEASETM IVC FILTER WAS DEPLOYED JUST BELOW THE RENAL VEIN. REPEAT INFERIOR VENA CAVOGRAM SHOWED THE VENA CAVA FILTER IN CORRECT POSITION. SIX HOURS AFTER THE PLACEMENT OF THE VENA CAVA FILTER, HEMOGLOBIN DROP FROM 9.3 DOWN TO 8.1 G/DL WAS NOTED. SHE WAS GIVEN A TRANSFUSION OF TWO UNITS OF BLOOD. OVER THE SUBSEQUENT 24 HOURS. SHE BECAME INCREASING UNSTABLE. COMPUTED TOMOGRAPHY (CT) SHOWED EVIDENCE OF HEMOPERITONEUM AND A MASSIVE RETROPERITONEAL HEMATOMA MEASURING 13.2 CM _ 8.3 CM ADJACENT TO THE INFERIOR VENA CAVA. THERE WAS THROMBUS WITHIN THE RIGHT COMMON AND EXTERNAL ILIAC VEINS, LEFT EXTERNAL ILIAC VEINS, AND LEFT COMMON FEMORAL VEIN. A VENOGRAM SHOWED THAT THE VENOUS FILTER WAS UNCHANGED IN POSITION. THE REPEAT HEMOGLOBIN DURING THE RESUSCITATION WAS 4.7 G/DL, AND THE PATIENT RECEIVED FIVE UNITS OF PACKED RED BLOOD CELLS (PRBC) AND TWO UNITS OF FRESH FROZEN PLASMA (FFP). LOW MOLECULAR WEIGHT HEPARIN WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252594 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R