BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 3212802 · Received July 9, 2013

    Report

    Report Number
    9616099-2013-00428
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    September 16, 2009
    Report Date
    June 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO PROTECT AGAINST CAVAL THROMBUS DISLODGEMENT AND PE DURING RETRIEVAL, A SEPARATE OPTEASE FILTER WAS THEN INSERTED UNDER FLUOROSCOPY THROUGH THE RIGHT INTERNAL JUGULAR VEIN AND DEPLOYED UNEVENTFULLY BELOW THE LEVEL OF THE HEPATIC VEINS IN A SUPRA-RENAL POSITION. VASCULAR ACCESS TO THE LEFT CFV WAS THEN UPSIZED TO ACCOMMODATE A 10-F VASCULAR SHEATH AND THE MALPOSITIONED OPTEASE FILTER RETRIEVED WITHOUT INCIDENCE, USING THE OPTEASE RETRIEVAL SET AND A GOOSE-SNARE. COMPLETION CAVOGRAM SHOWED GOOD POSITION OF THE SUPRA-RENAL FILTER. POST-RETRIEVAL EXAMINATION OF THE OPTEASE FILTER SHOWED PRESENCE OF THROMBUS ALONG THE SIDE STRUTS OF THE FILTER. THE OPTEASE FILTER WAS LEFT IN-SITU AND THE PATIENT HAD NO FILTER RELATED COMPLICATION WHEN SEEN AT A FOLLOW-UP AFTER 6 MONTHS. THE LITERATURE ARTICLE HAS BEEN ATTACHED TO THIS MDR REPORT. PUA, U (2010, 12). INADVERTENT PERITHROMBUS DEPLOYMENT OF OPTEASE VENA CAVA FILTER: USE OF DOUBLE-FILTER TECHNIQUE FOR PULMONARY EMBOLISM PROTECTION DURING RETRIEVAL OF MALPOSITIONED FILTER. J HK COLL RADIOL, 12 166-9. ADDIITONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: PUA ET AL IN INADVERTENT PERITHROMBUS DEPLOYMENT OF OPTEASE VENA CAVA FILTER: USE OF DOUBLE-FILTER TECHNIQUE FOR PULMONARY EMBOLISM PROTECTION DURING RETRIEVAL OF MALPOSITIONED FILTER; J HK COLL RADIOL. 2010;12:166-9; DESCRIBE A CASE REPORT OF A (B)(6) MAN WAS FOUND TO HAVE EXTENSIVE DEEP VENOUS THROMBOSIS (DVT) DURING CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN AND PELVIS PERFORMED AS PART OF HIS POST-LAPAROTOMY SEPTIC WORKUP. THE IMAGE (NOT SHOWN) INDICATED DVT EXTENDING FROM THE RIGHT COMMON FEMORAL VEIN (CFV) TO THE LEVEL OF THE RIGHT COMMON ILIAC VEIN BUT NO APPARENT CAVAL INVOLVEMENT WAS DETECTED IN THE COURSE OF HIS POST-LAPAROTOMY SEPTIC WORK-UP CT. ON THE FOLLOWING DAY, A PROPHYLACTIC IVC FILTER WAS INSERTED UNDER FLUOROSCOPIC GUIDANCE. AFTER ULTRASOUND GUIDED PUNCTURE OF THE LEFT CFV, A CAVOGRAM WAS OBTAINED THROUGH THE SHEATH OF THE OPTEASE RETRIEVABLE VENA CAVA FILTER SET (CORDIS, WARREN, NJ, US) [FIGURE 1]. THE OPERATOR FAILED TO RECOGNISE THE PRESENCE OF ECCENTRIC CAVAL THROMBUS ON THE CAVOGRAM (FIGURE 1, ARROW) AND SUBSEQUENTLY DEPLOYED THE FILTER BELOW THE LEVEL OF THE RENAL VEINS, UNKNOWINGLY ALONGSIDE THE CAVAL THROMBUS, IN A PERITHROMBUS POSITION (FIGURE 2). COMPLETION CAVOGRAM SHOWED INCOMPLETE OPENING OF THE FILTER, WITH COMPRESSION OF THE FILTER BY THE CAVAL THROMBUS. IN ADDITION, ONLY THE LATERAL ASPECT OF THE FILTER WAS APPOSING AND ANCHORED ON THE CAVAL WALL, WHILE THE MEDIAL ASPECT WAS PARTLY ANCHORED ON THE THROMBUS ITSELF. OWING TO THE INCOMPLETE FILTER OPENING WITH POOR CAVAL WALL APPOSITION, THE FILTER WAS AT RISK OF MIGRATION AND EMBOLISATION, AND THEREFORE NEEDED RE-SITTING. FURTHERMORE, INCOMPLETE FILTER OPENING CONSTITUTED INEFFECTIVE PROTECTION AGAINST PE. ALTHOUGH REPOSITIONING BY SIMPLE FILTER RETRIEVAL AND REDEPLOYMENT IN A SUPRA-RENAL POSITION WAS FEASIBLE, DISLODGEMENT LEADING TO EMBOLISATION OF THE CAVAL THROMBUS DURING FILTER MANIPULATION AND RETRIEVAL WAS A CONCERN, THIS WAS PARTICULARLY WORRYING AS THE CAVAL THROMBUS WAS PROBABLY FRESH, NOT HAVING BEEN PRESENT ON THE PREVIOUS DAY¿S CT. TO PROTECT AGAINST CAVAL THROMBUS DISLODGEMENT AND PE DURING RETRIEVAL, A SEPARATE OPTEASE FILTER WAS THEN INSERTED UNDER FLUOROSCOPY THROUGH THE RIGHT INTERNAL JUGULAR VEIN AND DEPLOYED UNEVENTFULLY BELOW THE LEVEL OF THE HEPATIC VEINS IN A SUPRA-RENAL POSITION (FIGURE 3). VASCULAR ACCESS TO THE LEFT CFV WAS THEN UPSIZED TO ACCOMMODATE A 10-F VASCULAR SHEATH AND THE MALPOSITIONED OPTEASE FILTER RETRIEVED WITHOUT INCIDENCE, USING THE OPTEASE RETRIEVAL SET AND A GOOSE-SNARE. COMPLETION CAVOGRAM SHOWED GOOD POSITION OF THE SUPRA-RENAL FILTER (FIGURE 4). POST-RETRIEVAL EXAMINATION OF THE OPTEASE FILTER SHOWED PRESENCE OF THROMBUS ALONG THE SIDE STRUTS OF THE FILTER. THE OPTEASE FILTER WAS LEFT IN-SITU (REFERRING PHYSICIAN¿S DECISION) AND THE PATIENT HAD NO FILTER RELATED COMPLICATION WHEN SEEN AT A FOLLOW-UP AFTER 6 MONTHS. MIGRATION IS A RARE BUT POTENTIALLY FATAL COMPLICATION OF IVC FILTERS. FILTER MALPOSITION AND INCOMPLETE OPENING ARE KNOWN RISK FACTORS AND THEIR OCCURRENCE NEEDS TO BE IDENTIFIED AND IF POSSIBLE RECTIFIED IN THE IMMEDIATE POST DEPLOYMENT PERIOD, AS PROCRASTINATION INCREASES THE DIFFICULTY IN RETRIEVAL AND REPOSITIONING. 5 RETRIEVABLE IVC FILTERS ARE GAINING POPULARITY AS THEY CAN BE DEPLOYED TEMPORARILY AND IN OUR CASE, THIS CHARACTERISTIC PROVED TO BE ESPECIALLY ADVANTAGEOUS. THE DOUBLE-FILTER TECHNIQUE WAS FIRST DESCRIBED BY NOMURA ET AL WHERE AN ADDITIONAL IVC FILTER WAS PLACED TO CAPTURE DISLODGED THROMBUS WHILE RETRIEVING A THROMBUS-FILLED RETRIEVABLE FILTER. IN OUR CASE, THE RISK OF THROMBUS DISLODGEMENT DURING RETRIEVAL WAS PROBABLY JUST AS GREAT AS THE CAVAL THROMBUS APPEARED TO BE FRESH AND UNRESTRAINED, AND LOCATED OUTSIDE THE DEPLOYED IVC FILTER. THIS CASE ILLUSTRATES HOW OPERATORS CAN AND PERHAPS SHOULD EXPLOIT THE RETRIEVABLE PROPERTY OF RETRIEVABLE IVC FILTERS TO CORRECT SEVERE FILTER MALPOSITION AND OTHER PROBLEMS IMMEDIATELY POST-DEPLOYMENT. IF THE PE RISK DURING RETRIEVAL IS DEEMED HIGH, CRANIAL PLACEMENT OF AN ADDITIONAL IVC FILTER (RESULTING IN A DOUBLE FILTER) CAN SERVE TO ALLOW SAFE FILTER RETRIEVAL. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. BASED ON THE INFORMATION PROVIDED IN THE ARTICLE, THERE ARE PATIENT FACTORS (PRE-EXISTING THROMBUS) AND PROCEDURAL FACTORS (OPERATOR FAILED TO RECOGNIZE THE PRESENCE OF ECCENTRIC CAVAL THROMBUS ON THE CAVOGRAM AND SUBSEQUENTLY DEPLOYED THE FILTER UNKNOWINGLY ALONGSIDE THE CAVAL THROMBUS) THAT CONTRIBUTED TO THE PRODUCT EXPERIENCE DESCRIBED IN THE ARTICLE. THE INCOMPLETE EXPANSION OF THE FILTER WAS REPORTED TO BE DUE TO COMPRESSION OF THE FILTER BY THE CAVAL THROMBUS. IN ADDITION, ONLY THE LATERAL ASPECT OF THE FILTER WAS APPOSING AND ANCHORED ON THE CAVAL WALL, WHILE THE MEDIAL ASPECT WAS PARTLY ANCHORED ON THE THROMBUS ITSELF. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, A PATIENT WAS FOUND TO HAVE EXTENSIVE DEEP VENOUS THROMBOSIS (DVT) DURING CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN AND PELVIS PERFORMED AS PART OF HIS POST-LAPAROTOMY SEPTIC WORKUP. THE IMAGE INDICATED DVT EXTENDING FROM THE RIGHT COMMON FEMORAL VEIN (CFV) TO THE LEVEL OF THE RIGHT COMMON ILIAC VEIN BUT NO APPARENT CAVAL INVOLVEMENT WAS DETECTED IN THE COURSE OF HIS POST-LAPAROTOMY SEPTIC WORK-UP CT. ON THE FOLLOWING DAY, A PROPHYLACTIC IVC FILTER WAS INSERTED UNDER FLUOROSCOPIC GUIDANCE. AFTER ULTRASOUND GUIDED PUNCTURE OF THE LEFT CFV, A CAVOGRAM WAS OBTAINED THROUGH THE SHEATH OF THE OPTEASE RETRIEVABLE VENA CAVA FILTER THE OPERATOR FAILED TO RECOGNIZE THE PRESENCE OF ECCENTRIC CAVAL THROMBUS ON THE CAVOGRAM AND SUBSEQUENTLY DEPLOYED THE FILTER BELOW THE LEVEL OF THE RENAL VEINS, UNKNOWINGLY ALONGSIDE THE CAVAL THROMBUS, IN A PERITHROMBUS POSITION. COMPLETION CAVOGRAM SHOWED INCOMPLETE OPENING OF THE FILTER, WITH COMPRESSION OF THE FILTER BY THE CAVAL THROMBUS. IN ADDITION, ONLY THE LATERAL ASPECT OF THE FILTER WAS APPOSING AND ANCHORED ON THE CAVAL WALL, WHILE THE MEDIAL ASPECT WAS PARTLY ANCHORED ON THE THROMBUS ITSELF. OWING TO THE INCOMPLETE FILTER OPENING WITH POOR CAVAL WALL APPOSITION, THE FILTER WAS AT RISK OF MIGRATION AND EMBOLISATION AND THEREFORE NEEDED RE-SITTING. FURTHERMORE, INCOMPLETE FILTER OPENING CONSTITUTED INEFFECTIVE PROTECTION AGAINST PE. ALTHOUGH REPOSITIONING BY SIMPLE FILTER RETRIEVAL AND REDEPLOYMENT IN A SUPRA-RENAL POSITION WAS FEASIBLE, DISLODGEMENT LEADING TO EMBOLISATION OF THE CAVAL THROMBUS DURING FILTER MANIPULATION AND RETRIEVAL WAS A CONCERN. THIS WAS PARTICULARLY WORRYING AS THE CAVAL THROMBUS WAS PROBABLY FRESH, NOT HAVING BEEN PRESENT ON THE PREVIOUS DAY¿S CT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314179 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR