BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 2953846 · Received January 31, 2013

    Report

    Report Number
    1820334-2013-00065
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 4, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMOVAL OF FOREIGN BODY IS NOT LABELED. DIFFICULT TO DEPLOY IS LABELED. THE PRODUCT WAS RECEIVED AND DECONTAMINATED. NO IMAGES WERE PROVIDED. RETURNED FILTER WAS FOUND SYMMETRIC AND IN NORMAL SHAPE. THE DIAGONAL BETWEEN TWO PRIMARY LEGS WAS WITHIN SPECIFICATIONS. NO SIGH OF DEFECT/DEFORMATION OF PRIMARY NOR SECONDARY LEGS, AND THERE IS NO INDICATION WHY THE FILTER "WAS NOT COMPLETELY EXPANDED AND SIGNIFICANTLY TILTED" BUT THE FILTER MAY HAVE BEEN SOMEHOW OBSTRUCTED FROM FULLY EXPANDING DUE TO IVC ANATOMICAL CONDITIONS. IN THE MFG PROCESS THE FILTER AND THE INTRODUCER SYS ARE INSPECTED. NO OTHER COMPLAINTS HAVE BEEN REC'D ON THIS PROVIDED LOT NUMBER. THE PRODUCT IS SHIPPED WITH INSTRUCTION FOR USE WHICH LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS, AND PRECAUTIONS AND THE CORRECT DEPLOYMENT PROCEDURE. THE COMPLAINT WAS CONFIRMED PER THE CUSTOMER STATEMENT OF THE EVENT AS THE RETURNED FILTER WAS FOUND SYMMETRIC AND IN NORMAL SHAPE. IF THE FILTER IS DEPLOYED IN A SMALL/FLAT VENA CAVA, THE FILTER WOULD NOT FULLY EXPAND BEFORE THE VENA CAVA IS NORMAL IN SHAPE. THIS UN UNCOMMON, BUT KNOW RISK DOCUMENTED IN THE LITERATURE. REFERENCE IS MADE TO THE FOLLOWING ARTICLE: C.A. OWENS, J.T.BUI, M.G. KNUTTTINEN, R.C. GABA, T.C. CARRILLO, N.HOEFLING, AND J.E. LAYDEN-ALMER, INTRACARDIAC MIGRATION OF INFERIOR VENA CAVA FILTERS: REVIEW OF THE PUBLISHED DATA, CHEST, (2009). WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL.

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH BILATERAL LOWER EXTREMITY DEEP VEIN THROMBOSIS (WHILE ON ADEQUATE ANTICOAGULATION) REQUIRES PROPHYLAXIS FOR PULMONARY EMBOLISM. SHE UNDERWENT IVC FILTER PLACEMENT ON (B)(6) 2012. THERE WERE NO IMMEDIATE COMPLICATIONS. CONTINUOUS PHYSIOLOGICAL MONITORING WAS ADMINISTERED THROUGHOUT THE PROCEDURE. WITH THE PT IN THE SUPINE POSITION THE RIGHT INGUINAL REGION WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. PULMONARY SONOGRAPHIC EXAM OF THE RIGHT INGUINAL REGION DEMONSTRATES COMPRESSIBILITY OF THE RIGHT FEMORAL VEIN WITH NO EVIDENCE OF INTRALUMINAL THROMBUS. USING REAL TIME SONOGRAPHIC GUIDANCE THE RIGHT COMMON FEMORAL VEIN WAS CATHETERIZED WITH A 21 GAUGE MICROPUNCTURE NEEDLE. A WIRE WAS INSERTED INTO THE RIGHT FEMORAL VEIN. A MICROVASCULAR SHEATH WAS PLACED. A SMALL AMOUNT OF CONTRAST WAS INJECTED DEMONSTRATING PATENCY OF THE RIGHT ILIAC VENOUS SYSTEM. THIS WA EXCHANGED FOR A 5 FR. VASCULAR SHEATH OVER A BENSTON WIRE. THE GLIDEWIRE WAS USED TO SELECT THE LEFT ILIAC VEIN AND A 4FR. CATHETER OF ANOTHER MFR WAS ADVANCED INTO LEFT COMMON ILIAC VEIN. DIGITAL SUBTRACTION ANGIOGRAPHY WAS PERFORMED. IMAGES DEMONSTRATE THE ORIGINS OF TH RENAL VEINS AS WELL AS SEVERAL SMALLER VEINS INFERIORLY. THE CATHETER WAS EXCHANGED FOR A 4 FR (COBRA) CATHETER OF ANOTHER KIND WHICH WAS USED TO SELECT ONE OT THE VEINS INFERIOR TO LEFT RENAL VEIN. CONTRAST WAS HAND INJECTED DEMONSTRATING THIS VEIN TO BE A PARAVERTEBRAL VEIN, NOT IN DIRECT CONTINUITY WITH THE LEFT RENAL VEIN BUT DRAINING INTO IT VIA A SMALL VENOUS PLEXUS. A GUNTHER TULIP FILTER WAS THEN PLACED USING TH SUPPLIED SHEATH BELOW THE LEVEL OF THE LEFT RENAL VEIN. AFTER DEPLOYMENT, CONTRAST WAS INJECTED DEMONSTRATING THAT THE FILTER WAS NOT COMPLETELY EXPANDED AND SIGNIFICANTLY TILTED. THIS WAS FELT WITH THE PT AT RISK FOR FILTER EMBOLIZATION. THE FILTER WAS RETRIEVED VIA AN INTERNAL JUGULAR VEIN APPROACH AND REPLACED WITH ANOTHER MFR'S (VENA TECH) FILTER IN GOOD POSITION AND IS DESCRIBED AS A SEPARATE PROCEDURE. THE RIGHT FEMORAL SHEATH WAS REMOVED AND COMPRESSION WAS APPLIED TO THE RIGHT INGUINAL REGION UNTIL ADEQUATE HEMOSTATS WAS ACHIEVED. FILTER WAS RETRIEVED AND THE PT TOLERATED THE PROCEDURE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42036 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA 3600759

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention