BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2429148 · Received January 26, 2012

    Report

    Report Number
    9616099-2012-00045
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 10, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PHLEBOGRAPHY THROUGH THE RIGHT FEMORAL VEIN SHOWED THROMBUS IN THE LEFT COMMON ILIAC VEIN, WHICH EXTENDED INTO THE RIGHT COMMON ILIAC VEIN, AND THUS, FILTER PLACEMENT WAS PERFORMED THROUGH THE RIGHT JUGULAR VEIN. AFTER 4 DAYS, THE SYMPTOMS OF THE PATIENT HAD DECREASED SUBSTANTIALLY AND FILTER RETRIEVAL WAS PLANNED. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. CONCOMITANT DEVICES (RETRIEVAL PROCEDURE): 5-F PIER CATHETER, 0.035 INCH HYDROPHILIC GUIDEWIRE (TERUMO, (B)(4)),A 0.035 INCH STIFF AMPLATZ GUIDEWIRE (COOK, (B)(4)) AND A CORDIS 12 MM OPTA PTA BALLOON. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. FILTER TILTING IS A KNOWN POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU AS SUCH AND OCCURS IN APPROXIMATELY 5.5% OF ALL CASES. TYPICALLY, FILTER TILT CAN LEAD TO A PROLONGED RETRIEVAL TIME AND HAS NO ADVERSE EFFECT UPON THE PATIENT. IT IS UNKNOWN IF THERE WERE DEPLOYMENT, VESSEL OR PROCEDURAL ISSUES THAT PRE-DISPOSED THE FILTER TO TILT. AS SUCH, WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    VINK ET AL IN BALLOON-ASSISTED RETRIEVAL OF TILTED OPTEASE IVC FILTER, CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, DOI: 10.1007/S00270-011-0332-6ONLINE FIRST. REPORT 4 DAYS AFTER A PATIENT WAS TREATED WITH AN OPTEASE FILTER; PHLEBOGRAPHY THROUGH THE RIGHT FEMORAL VEIN DID NOT SHOW ANY RESIDUAL THROMBOSIS. HOWEVER, THE OPTEASE IVC FILTER WAS TILTED TO THE RIGHT SIDE OF THE INFRARENAL CAVAL WALL AND COULD NOT BE RETRIEVED BY USING THE CONVENTIONAL SNARING TECHNIQUE. WITH THE SAME BALLOON-ASSISTED TECHNIQUE AS DESCRIBED IN THE FIRST CASE, THE TILT OF THE FILTER COULD BE NEUTRALIZED, THE HOOK OF THE IVC FILTER BECAME ACCESSIBLE, AND THE FILTER COULD BE REMOVED SAFELY. THE IVC FILTER WAS CATHETERIZED THROUGH THE CONTRALATERAL LEFT COMMON FEMORAL VEIN WITH A 5-F PIER CATHETER AND A 0.035 INCH HYDROPHILIC GUIDEWIRE (TERUMO, (B)(4)), WHICH WAS SUBSEQUENTLY EXCHANGED FOR A 0.035 INCH STIFF AMPLATZ GUIDEWIRE (COOK, (B)(4)). UNDER FLUOROSCOPIC GUIDANCE, A 12 MM OPTA PTA BALLOON (CORDIS) WAS ADVANCED OVER THE GUIDEWIRE THROUGH THE STRUTS OF THE FILTER INTO ITS LUMEN AND WAS SUBSEQUENTLY INFLATED WITH A MIX OF CONTRAST MATERIAL (50%) AND SALINE (50%). GENTLE TRACTION ON THE BALLOON CATHETER ENABLED US TO NEUTRALIZE THE POSITION OF THE FILTER WITHIN THE IVC AND TO REMOVE THE TILT IN RELATION TO THE CAVAL WALL. WITH CONTINUED TRACTION FROM THE LEFT SIDE, IT WAS RELATIVE EASY TO SNARE THE HOOK OF THE FILTER AND THE FILTER COULD BE REMOVED IN THE NORMAL FASHION THROUGH THE RIGHT FEMORAL SIDED GUIDING CATHETER. THE PATIENT WAS A 29(B)(6) WOMAN WHO PRESENTED WITH A PAINFUL MASSIVE THROMBUS IN THE LEFT COMMON ILIAC VEIN AND COMPRESSION OF THE PROXIMAL PART OF THE VEIN BY THE LEFT COMMON ILIAC ARTERY, SUGGESTIVE OF A MAY-THURNER SYNDROME. INITIAL PERCUTANEOUS INTRAVENOUS THROMBOLYSIS WAS PLANNED, PRECEDED BY THE PLACEMENT OF A RETRIEVABLE OPTEASE FILTER TO PREVENT PULMONARY EMBOLISM DUE TO CLOT INSTABILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R