BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3960619 · Received July 16, 2014

    Report

    Report Number
    3002808486-2014-00026
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    February 20, 2013
    Report Date
    June 16, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL DEVICE INFO: LOT# UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG #: UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS COOK CELECT INFERIOR VENA CAVA. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO DEVICE, IMAGING STUDIES OR COMPLETE HOSPITAL MEDICAL RECORDS HAVE BEEN AVAILABLE. CONSEQUENTLY, BASED ON VERY LIMITED INFORMATION IT IS DIFFICULT TO COMMENT ON THE ALLEGED FILTER PERFORATION AND DIFFICULT FILTER REMOVAL. FILTER PERFORATION OF VENA CAVA WALL AND DIFFICULT REMOVAL OF VENA CAVA FILTERS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. THE EXACT ROOT CAUSE FOR THE ALLEGED FILTER PERFORATION AND DIFFICULT FILTER REMOVAL CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. MONITORING OF SIMILAR REPORTS WILL CONTINUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "CELECT, TILT, VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED, OTHER: EMBEDMENT". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. AS NO DEVICE, IMAGING STUDIES OR HOSPITAL OR MEDICAL RECORDS HAVE BEEN AVAILABLE. CONSEQUENTLY, BASED ON VERY LIMITED INFORMATION IT IS DIFFICULT TO COMMENT ON THE ALLEGED FILTER HOOK PERFORATION. INSTRUCTIONS FOR USE LIST DAMAGE TO THE VENA CAVA, AND VENA CAVA PERFORATION AS POTENTIAL ADVERSE EVENTS. SUCH EVENTS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. THE EXACT ROOT CAUSE FOR THE ALLEGED FILTER HOOK PERFORATION AND DIFFICULT RETRIEVAL CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ALLEGATIONS ACCORDING TO COMPLAINANT: ON (B)(6) 2013: ATTEMPTED FILTER RETRIEVAL. FINDINGS: TILTED IVC FILTER, HOOK OUTSIDE CAVAL WALL, UNABLE TO RETRIEVE. VENA CAVAGRAM REVEALED SIGNIFICANTLY TILTED FILTER WITH THE HOOK OF THE FILTER PROTRUDING OUTSIDE VENA CAVA. A SNARE WAS INTRODUCED BUT IMPOSSIBLE TO CATCH THE FILTER. LOOP WAS FORMED, AND THE LOOP WAS RETRIEVED BACK GRASPING THE TOP OF THE FILTER AND DESPITE SEVERAL ATTEMPTS TO DEVIATE THE HOOK OF THE FILTER INTRALUMINALLY AND EVENTUALLY SHEATH IT, THIS PROVED INEVITABLE. RETRIEVAL PROCEDURE TERMINATED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 02/07/2017 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT FEMORAL VEIN DUE TO RISK OF DVTS & PES. THE PATIENT ALLEGEDLY HAD AN UNSUCCESSFUL REMOVAL ATTEMPT PERFORMED VIA GROIN & JUGULAR ACCESS POINTS ON (B)(6) 2013. PLAINTIFF IS ALLEGING TILT, VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED, OTHER: EMBEDMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416077 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| O