BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2429120 · Received January 26, 2012

    Report

    Report Number
    9616099-2012-00044
    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

    IN THE RIGHT COMMON FEMORAL VEIN. INTRACUTANEOUS LOWMOLECULAR-WEIGHT HEPARIN WAS ADMINISTERED AFTER THE PROCEDURE. AFTER 2 WEEKS, THE BLEEDING AROUND THE KNEE HAD STOPPED, ANTICOAGULATION THERAPY WAS CONTINUED AND RETRIEVAL OF THE IVC FILTER 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 TWO WEEKS AFTER A PATIENT WAS TREATED WITH AN OPTEASE FILTER, CONTROL PHLEBOGRAPHY THROUGH THE RIGHT FEMORAL VEIN SHOWED NO THROMBUS IN THE FILTER BUT TILTING OF THE IVC FILTER AGAINST THE RIGHT SIDE OF THE CAVAL WALL. BECAUSE OF THIS TILT, THE HOOK OF THE FILTER COULD NOT BE CAUGHT WITH A CONVENTIONAL SNARING TECHNIQUE WITH A 25 MM AMPLATZ GOOSE NECK SNARE (EV3, (B)(4)) AND 10-F GUIDING CATHETER (CORDIS). THE IVC FILTER WAS THEN 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. AT THE INITIAL PLACEMENT OF THE FILTER, THE (B)(6) WOMAN DEVELOPED MASSIVE PULMONARY EMBOLISMS SHORTLY AFTER TOTAL KNEE ARTHROPLASTY. ANTICOAGULATION THERAPY WAS INITIATED BUT HAD TO BE SUSPENDED BECAUSE OF PERSISTENT BLEEDING AT THE OPERATIVE SITE THAT CAUSED COMPARTMENT SYNDROME OF THE RIGHT LOWER LEG. TO PREVENT FURTHER THROMBOEMBOLIC COMPLICATIONS, A RETRIEVABLE OPTEASE (CORDIS, (B)(4)) IVC FILTER WAS PLACED IN THE INFRARENAL VENA CAVA THROUGH A 6-F SHEATH.

    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 55 YR Required Intervention