BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE FILTER SYSTEM

    MDR report key: 3232291 · Received July 10, 2013

    Report

    Report Number
    2020394-2013-00200
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    July 19, 2011
    Report Date
    June 20, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K096359
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR FILTER LIMB DETACHMENT. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED BASED UPON THE AVAILABLE INFO. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES.

    Additional Manufacturer Narrative · 1

    BASED ON MEDICAL RECORDS AND IMAGES REVIEWED: PATIENT ADMITTED ON (B)(6) 2010, TWO WEEKS POST ABDOMINOPLASTY AND BREAST REDUCTION FOR COMPLAINTS OF LOWER LEFT EXTREMITY PAIN AND SWELLING. ULTRASOUND CONFIRMED DVT IN THE LEFT LOWER EXTREMITY. A BARD ECLIPSE FEMORAL IVC FILTER WAS IMPLANTED PRIOR TO A PERCUTANEOUS ANGIOJET MECHANICAL THROMBECTOMY FROM THE COMMON FEMORAL VEIN TO THE POPLITEAL VEIN. AN ESTIMATED 80% THROMBUS WAS REMOVED FROM THE VEIN. THE PATIENT HAD NO REPORTED ADDITIONAL EPISODES OF THROMBOSIS. THE BARD ECLIPSE IVC FILTER WAS REMOVED SUCCESSFULLY APPROXIMATELY FOUR MONTHS POST DEPLOYMENT. THE FILTER RETRIEVAL PROCEDURAL REPORT DID NOT IDENTIFY A DETACHED FILTER LIMB FOLLOWING THE SUCCESSFUL RETRIEVAL OF THE VENA CAVA FILTER. APPROXIMATELY ONE MONTH LATER, THE PATIENT PRESENTED TO THE ER WITH COMPLAINT OF CHEST PAIN, A CT PULMONARY ANGIOGRAM DEMONSTRATED NO ABNORMAL RESULTS. APPROXIMATELY FIVE MONTHS POST FILTER RETRIEVAL, A CT SCAN DEMONSTRATED A SMALL PERICARDIAL EFFUSION AND THIN WIRE LIKE METALLIC DENSITY ALONG THE INFERIOR ASPECT OF THE PERICARDIUM. CONSULT WITH A CARDIOTHORACIC SURGEON REVEALED THAT RETRIEVING THE METAL WOULD CAUSE MORE HARM THAN GOOD. APPROXIMATELY THREE MONTHS POST CONSULT, A CT SCAN DEMONSTRATED A LINEAR METALLIC DENSITY IN THE PERICARDIAL SPACE AND A RESOLVED PERICARDIAL EFFUSION. NINE MONTHS POST FILTER RETRIEVAL, THE PATIENT PRESENTED TO THE ER WITH COMPLAINT OF CHEST PAIN, A CT SCAN DEMONSTRATED A SMALL PERICARDIAL EFFUSION AND NO OTHER SIGNIFICANT ABNORMALITIES. THREE DAYS LATER, A TEE DEMONSTRATED A SMALL PERICARDIAL EFFUSION WITH NO EVIDENCE OF HEMODYNAMIC COMPROMISE. A CARDIOLOGIST REVIEWED THE CT SCAN AND CONFIRMED THE PERICARDIAL EFFUSION BUT SAW NO EVIDENCE OF A METALLIC LINEAR DENSITY IN THE CHEST. ADDITIONAL TESTING OF EKGS, HALTER MONITORING AND AN EXERCISE STRESS TEST DEMONSTRATED NO ISCHEMIA OR ARRHYTHMIA IDENTIFIED. APPROXIMATELY 27 MONTHS POST FILTER RETRIEVAL A TEE DEMONSTRATED NORMAL LEFT VENTRICULAR FUNCTION, MILD MITRAL VALVE AND TRICUSPID VALE REGURGITATION AND NO EVIDENCE OF PERICARDIAL EFFUSION. A CONSULT WITH ANOTHER CARDIOTHORACIC SURGEON WHO FELT THE PIECE OF WIRE WAS SCARRED IN WITH NO IMMINENT THREAT TO HER CIRCULATION AND RECOMMENDED NON OPERATIVE TREATMENT. NO OTHER INFORMATION WAS PROVIDED IF AN ATTEMPT WAS MADE TO REMOVE THE METALLIC LINEAR DENSITY. IMAGE REVIEW: BASED ON IMAGES PROVIDED, A VENA CAVA FILTER WAS SUCCESSFULLY PLACED INFERIOR TO THE RENAL TAKEOFFS IN AN UPRIGHT POSITION, CAN BE CONFIRMED. BASED ON THE IMAGES PROVIDED, FILTER TILT CAN BE CONFIRMED. BASED ON IMAGES PROVIDED, SUCCESSFUL REMOVAL OF THE VENA CAVA FILTER CAN BE CONFIRMED. BASED ON IMAGES PROVIDED, A CURVED LINEAR METALLIC OBJECT IN THE HEART CAN BE CONFIRMED; HOWEVER, THE IDENTITY OF THE CURVED LINEAR METALLIC OBJECT IN THE HEART CANNOT BE CONFIRMED. DATE OF IMPLANT: (CORRECTION) (B)(6) 2010 DELETED; CORRECTION (B)(6) 2010. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE PRODUCT CATALOG NUMBER HAS BEEN PROVIDED AND INVESTIGATION OF THE REPORTED EVENT COMPLETED. BASED ON THE MEDICAL RECORDS AND IMAGES RECEIVED, A LINEAR METALLIC OBJECT IN THE HEART CAN BE CONFIRMED; HOWEVER IT IS UNKNOWN IF THE METALLIC OBJECT IS A FILTER LIMB AS A DETACHED LIMB WAS NOT REPORTED DURING RETRIEVAL AND THE NUMBER OF LIMBS COULD NOT BE IDENTIFIED FROM THE IMAGES PROVIDED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR A DETACHED FILTER LIMB. IMAGING DEMONSTRATED THE FILTER TO BE TILTED APPROXIMATELY 25°. THE INVESTIGATION IS CONFIRMED FOR FILTER TILT. UNABLE TO DETERMINE THE ROOT CAUSE BASED UPON THE AVAILABLE INFORMATION. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS; FILTER TILT; FILTER MALPOSITION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS HAVE BEEN RECEIVED AND ARE BEING REVIEWED. THE INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS AFTER A VENA CAVA FILTER IMPLANTATION, THE FILTER WAS SUCCESSFULLY REMOVED DURING A SCHEDULED RETRIEVAL. APPROXIMATELY FIVE MONTHS AFTER REMOVAL OF THE FILTER, A CT SCAN DEMONSTRATED A FRAGMENT OF THE VENA CAVA FILTER THAT HAD PENETRATED THE VENTRICLE AND WAS LOCATED IN THE PERICARDIAL SPACE. NO OTHER INFORMATION HAS BEEN PROVIDED. THE CURRENT PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316057 ECLIPSE FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening