BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 6038609 · Received October 18, 2016

    Report

    Report Number
    2020394-2016-00984
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    July 19, 2012
    Report Date
    February 8, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED. VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: BASED ON THE MEDICAL RECORD REVIEW THAT WAS PERFORMED BY SLP (STRATEGIC LITIGATION PARTNERS), A MEDICAL RECORD REVIEW SUMMARY HAS BEEN COMPLETED. A VENA CAVA FILTER WAS INDICATED FOR A HISTORY OF DVT WITH RECENT RECURRENT PE DUE TO ANTICOAGULANT NON-COMPLIANCE AND AN UPCOMING THYMEMECTOMY. THE FILTER WAS SUCCESSFULLY DEPLOYED AT THE L2/L3 LEVEL VIA THE LEFT COMMON FEMORAL VEIN. APPROXIMATELY TWO MONTHS POST FILTER DEPLOYMENT, THE PATIENT WAS REFERRED TO DISCUSS REMOVAL OF THE FILTER. IT WAS DETERMINED THAT THE FILTER WOULD REMAIN UNTIL AFTER HER UPCOMING UMBILICAL HERNIA REPAIR. APPROXIMATELY FIVE MONTHS POST FILTER DEPLOYMENT, CT ANGIOGRAM DEMONSTRATED THE FILTER TO BE UNUSUALLY ALIGNED AND RIGHTWARD TILTED WITH FILTER LIMBS EXTENDING BEYOND THE CAVAL WALL. APPROXIMATELY SIX MONTHS POST FILTER DEPLOYMENT; DURING A VASCULAR FOLLOW-UP, THE PATIENT REQUESTED REMOVAL OF THE FILTER REPORTING SHE COULD FEEL IT STICKING OUT OF HER CHEST AND WAS UNCOMFORTABLE. ATTENDING PHYSICIAN FINDINGS REFERENCE AN UNSUCCESSFUL FILTER REMOVAL ATTEMPT DUE TO TILTING INTO THE LUMBAR VEINS AND PRONGS WHICH MIGHT BE STICKING OUT OF THE LATERAL CAVAL WALL. ADDITIONALLY, THE ATTENDING PHYSICIAN NOTED THAT THE PATIENT HAD CHRONIC ABDOMINAL PAIN AND UMBILICAL HERNIA REPAIR AND EXPLAINING THAT OPEN REMOVAL OF THE FILTER WOULD BE REQUIRED AS THE FILTER WAS EMBEDDED. HOWEVER, THIS WOULD ONLY BE ATTEMPTED IF THERE WAS A SIGNIFICANT COMPLICATION FROM THE FILTER. APPROXIMATELY SEVENTEEN MONTHS POST FILTER DEPLOYMENT, CT ANGIOGRAM DEMONSTRATED A SMALL LEFT BASILAR SEGMENTAL PULMONARY EMBOLUS WITH THE IVC FILTER UNCHANGED FROM PREVIOUS SCANS. APPROXIMATELY 19 MONTHS POST FILTER DEPLOYMENT, ANOTHER PERCUTANEOUS FILTER RETRIEVAL ATTEMPT WAS UNSUCCESSFUL. APPROXIMATELY TWO YEARS POST FILTER DEPLOYMENT, A THIRD ATTEMPT TO RETRIEVE THE FILTER UNDER GENERAL ANESTHESIA WAS UNSUCCESSFUL. APPROXIMATELY 27 MONTHS POST FILTER DEPLOYMENT, X-RAY DEMONSTRATED THE FILTER WITH ELEVEN LIMBS AND ONE SHORTENED LIMB VISUALIZED. PATHOLOGY CONFIRMED A SILVER METALLIC WIRE 2.4CM IN LENGTH X 0.1CM IN DIAMETER WAS REMOVED. A FOLLOW-UP CT CONFIRMED THE DETACHED FILTER LIMB WAS SUCCESSFULLY RETRIEVED FROM THE PULMONARY ARTERY. THREE DAYS LATER, OPEN VENOTOMY WAS PERFORMED TO SUCCESSFULLY REMOVE THE FILTER. PATHOLOGY CONFIRMED GROSSLY CONSISTENT SILVER METALLIC WIRES 5.1 X 1.0 X 1.0CM CONSISTENT WITH AN IVC FILTER. APPROXIMATELY ELEVEN DAYS POST FILTER REMOVAL, CT DEMONSTRATED HEMATOMA PRESENT LIKELY EXTERNAL TO THE IVC WITH MARKED COMPRESSION AT THE LEVEL WHERE THE FILTER PREVIOUSLY RESIDED. ADDITIONALLY, A LARGE HEMATOMA ALONG THE INFERIOR GALLBLADDER FOSSA AND THE INFERIOR EDGE OF THE LIVER WITHOUT EVIDENCE OF OBSTRUCTION WAS IDENTIFIED. APPROXIMATELY FOUR MONTHS EIGHTEEN DAYS POST FILTER REMOVAL, CT DEMONSTRATED A 6MM SEGMENT THOUGHT TO BE A PORTION OF RESIDUAL IVC FILTER LIMB EITHER WITHIN THE CAVAL WALL OR EXTERNAL TO THE VESSEL. THIS WAS PREVIOUSLY UNABLE TO BE FOUND DURING THE SURGICAL REMOVAL OF THE IVC FILTER. APPROXIMATELY FIVE MONTHS POST FILTER REMOVAL, CT FOR COMPLAINT OF ABDOMINAL PAIN IDENTIFIED THE DETACHED FILTER LIMB FRAGMENT TO BE UNCHANGED AND NO EXPLANATION FOR THE PATIENT¿S PAIN. APPROXIMATELY NINE MONTHS POST FILTER REMOVAL, CT SCANS PERFORMED IDENTIFIED THE DETACHED FILTER FRAGMENT TO BE UNCHANGED AND NO EVIDENCE OF ACUTE PATHOLOGY TO EXPLAIN THE PATIENT¿S COMPLAINT OF PAIN. IMAGE/PHOTO REVIEW: NO IMAGES OR PHOTOS HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. CONCLUSION: THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. A VENA CAVA FILTER WAS SUCCESSFULLY DEPLOYED AT THE L2/L3 LEVEL. FIVE MONTHS POST FILTER DEPLOYMENT, CT ANGIOGRAM IDENTIFIED THE FILTER TO BE TILTED WITH FILTER LIMBS EXTENDING BEYOND THE CAVAL WALL. APPROXIMATELY SIX MONTHS POST FILTER DEPLOYMENT DURING A VASCULAR FOLLOW-UP ATTENDING PHYSICIAN FINDINGS REFERENCE AN UNSUCCESSFUL FILTER REMOVAL ATTEMPT. SEVENTEEN MONTHS POST FILTER DEPLOYMENT, CT ANGIOGRAM DEMONSTRATED A SMALL LEFT BASILAR SEGMENTAL PULMONARY EMBOLUS. NINETEEN MONTHS POST FILTER DEPLOYMENT ANOTHER PERCUTANEOUS FILTER RETRIEVAL ATTEMPT WAS UNSUCCESSFUL. APPROXIMATELY TWO YEARS POST FILTER DEPLOYMENT, A THIRD ATTEMPT TO RETRIEVE THE FILTER UNDER GENERAL ANESTHESIA WAS UNSUCCESSFUL. TWENTY-SEVEN MONTHS POST FILTER DEPLOYMENT, X-RAY DEMONSTRATED THE FILTER WITH ELEVEN LIMBS AND ONE SHORTENED LIMB VISUALIZED. THREE DAYS LATER, OPEN VENOTOMY WAS PERFORMED TO SUCCESSFULLY REMOVE THE FILTER. BASED ON THE MEDICAL RECORDS THE INVESTIGATION CAN BE CONFIRMED FOR FILTER TILT, LIMB PERFORATION, AND DETACHMENT OF A FILTER LIMB. ADDITIONALLY, THE INVESTIGATION CAN BE CONFIRMED FOR PE POST FILTER DEPLOYMENT. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS; MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS; PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL; FILTER TILT; FILTER MALPOSITION; ACUTE OR RECURRENT PULMONARY EMBOLISM. THIS HAS BEEN REPORTED DESPITE FILTER USAGE. IT IS NOT KNOWN IF THROMBI PASSED THROUGH THE FILTER, OR ORIGINATED FROM SUPERIOR OR COLLATERAL VESSEL. NOTE: IT IS POSSIBLE THAT COMPLICATIONS SUCH AS THOSE DESCRIBED IN THE "WARNINGS", "PRECAUTIONS", OR "POTENTIAL COMPLICATIONS" SECTIONS OF THIS INSTRUCTIONS FOR USE MAY AFFECT THE RECOVERABILITY OF THE DEVICE AND RESULT IN THE CLINICIAN'S DECISION TO HAVE THE DEVICE REMAIN PERMANENTLY IMPLANTED. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENA CAVA FILTER WAS DEPLOYED SUCCESSFULLY, THE REASON FOR THE FILTER DEPLOYMENT WAS NOT PROVIDED. NO ALLEGED DEFICIENCY WITH THE DEVICE WAS REPORTED. NO OTHER INFORMATION REGARDING THIS EVENT WAS PROVIDED. THE PATIENT STATUS AT THIS TIME IS UNKNOWN. NEW INFORMATION RECEIVED: MEDICAL RECORDS WERE RECEIVED AND REVIEWED. APPROXIMATELY FIVE MONTHS POST VENA CAVA FILTER DEPLOYMENT, ANGIOGRAM DEMONSTRATED THE FILTER TO BE TILTED WITH FILTER LIMBS EXTENDING BEYOND THE CAVAL WALL. APPROXIMATELY SIX MONTHS POST FILTER DEPLOYMENT, REFERENCE WAS MADE (NO DATE WAS PROVIDED) TO AN UNSUCCESSFUL FILTER RETRIEVAL ATTEMPT. CT ANGIOGRAM PERFORMED APPROXIMATELY 17 MONTHS POST FILTER DEPLOYMENT DEMONSTRATED A SMALL LEFT BASILAR SEGMENTAL PULMONARY EMBOLUS. APPROXIMATELY 27 MONTHS POST FILTER DEPLOYMENT, X-RAY DEMONSTRATED A PORTION OF ONE FILTER LIMB TO HAVE DETACHED. THE DETACHED FILTER LIMB WAS SUCCESSFULLY RETRIEVED PERCUTANEOUSLY AND THREE DAYS LATER A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE FILTER. A SMALL FRAGMENT OF THE FILTER WAS THOUGHT TO REMAIN WITHIN OR EXTERNAL TO THE CAVAL WALL; HOWEVER COULD NOT FOUND AT THE TIME OF FILTER REMOVAL. THE FRAGMENT WAS NOT BELIEVED TO POSE ANY ONGOING MEDICAL RISK. THERE WERE NO REPORTED COMPLICATIONS. CT DEMONSTRATED HEMATOMA AT THE LEVEL WHERE THE FILTER PREVIOUSLY RESIDED APPROXIMATELY ELEVEN DAYS POST FILTER REMOVAL. APPROXIMATELY FOUR MONTHS EIGHTEEN DAYS POST FILTER REMOVAL, CT DEMONSTRATED A 6MM SEGMENT THOUGHT TO BE A PORTION OF RESIDUAL IVC FILTER LIMB EITHER WITHIN THE CAVAL WALL OR EXTERNAL TO THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688613 ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| L| R LOVENOX, COUMADIN, FRAGMIN, ARIXTRA