BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 3181550 · Received June 21, 2013

    Report

    Report Number
    9616099-2013-00390
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE IMPLANT DATE LISTED IN THE VOLUNTARY MEDWATCH REPORT STATES (B)(6) 2013 WITHOUT THE EXACT DAY. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A VOLUNTARY MEDWATCH REPORT WAS RECEIVED FROM THE ACCOUNT STATING THAT AN OPTEASE VENA CAVA FILTER WAS PLACED UPSIDE DOWN IN A PATIENT. THE FILTER HAS BEEN RETRIEVED. THE PATIENT IS A (B)(6) GENTLEMAN WHO WAS INVOLVED IN A MOTOR VEHICLE COLLISION AND SUSTAINED A DEEP INTRACEREBRAL BLEED IN THE FRONTOPARIETAL AREA. HE ALSO HAD A PELVIC FRACTURE AND DURING HIS HOSPITAL STAY DEVELOPED A RIGHT FEMORAL DEEP VEIN THROMBOSIS. BECAUSE OF THE INTRAPERITONEAL BLEED, THIS REPRESENTED A RELATIVE CONTRAINDICATION FOR THERAPEUTIC ANTICOAGULATION, AND AFTER DISCUSSION WITH THE PATIENT AND FAMILY DECISION WAS MADE FOR AN INFERIOR VENA CAVA FILTER, AND THUS THE INDICATION FOR THE PROCEDURE. THE PATIENT RETURNED TO THE SPECIAL PROCEDURES RADIOLOGY DEPARTMENT AT THE MEDICAL CENTER FOR REMOVAL OF AN INFERIOR VENA CAVA FILTER THAT WAS PLACED TO PREVENT DEEP VEIN THROMBOSIS (DVT). AN OPTEASE FILTER IS NOTED TO BE IN THE INFERIOR VENA CAVA AT APPROXIMATELY THE LEVEL OF THE RENAL VEINS; ITS HOOK IS DIRECTLY SUPERIORLY, REPRESENTING INVERSION OF ITS ANTICIPATED POSITION. THE DEVICE DID NOT MIGRATE OR TILT WHILE IN THE PATIENT. SUCCESSFUL RETRIEVAL OF THE OPTEASE INFERIOR VENA CAVA FILTER DEVICE WAS PERFORMED. THIS REQUIRED A SEPARATE ACCESS AND APPROACH FROM THE RIGHT INTERNAL JUGULAR VEIN. FURTHER INVESTIGATION FOUND THE SURGEON WHO PLACED THE FILTER THROUGH THE FEMORAL VEIN, HAD PLACED THE FILTER FOR JUGULAR RETRIEVAL AS HE ALWAYS HAD (UPSIDE DOWN). IT IS UNKNOWN THE ACTUAL NUMBER OF DEVICES THIS SURGEON HAS PLACED, BUT HE HAS BEEN USING THESE FILTERS A FEW YEARS. FOLLOW-UP WITH HIS MEDICAL SCHOOL AND RESIDENCY TRAINING PROGRAMS NEITHER CONFIRMED OR DENIED INSTRUCTION IN PLACING THE DEVICE THAT WAY. THERE WAS NO INJURY REPORTED DURING RETRIEVAL. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282219 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR