BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2183152 · Received July 28, 2011

    Report

    Report Number
    9616099-2011-00559
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 16, 2010
    Report Date
    July 12, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT FROM A JOURNAL ARTICLE ((B)(4)) STATES THAT THERE WAS INABILITY TO ENGAGE THE FILTER HOOK DURING RETRIEVAL OF THE OPTEASE VENA CAVA FILTER. RETRIEVAL WAS PERFORMED FROM A FEMORAL APPROACH. BRIEFLY, AFTER GAINING A VENOUS ACCESS, CAVOGRAPHY WAS PERFORMED TO RULE OUT INTRA-FILTER THROMBI. THE "SNARE AND SHEATH" TECHNIQUE USING 8-F SHEATH WAS USED. USUALLY A 15-MM SNARE WAS USED (AMPLATZ GOOSE NECK SNARE KIT). FAILURE TO ENGAGE THE HOOK WAS DEFINED AS LONG DURING UNSUCCESSFUL ATTEMPTS WITH MULTIPLE PRE-SHAPED CATHETERS AND DIFFERENT SNARE SIZES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PLEASE NOTE THAT THE FOLLOWING FOUR SERVICE REQUESTS ARE RELATED TO THIS THE SAME EVENT OF INABILITY TO ENGAGE THE FILTER HOOK DURING RETRIEVAL OF THE DEVICE AND ARE BEING REPORTED TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    RETRIEVAL WAS PERFORMED FROM A FEMORAL APPROACH. BRIEFLY, AFTER GAINING A VENOUS ACCESS, CAVOGRAPHY WAS PERFORMED TO RULE OUT INTRA-FILTER THROMBI. THE "SNARE AND SHEATH" TECHNIQUE USING 8-F SHEATH WAS USED. USUALLY A 15-MM SNARE WAS USED (AMPLATZ GOOSE NECK SNARE KIT). AFTER SNARING THE FILTER HOOK, THE SHEATH WAS ADVANCED OVER THE FILTER AND THE DEVICE REMOVED LEAVING THE SHEATH TO PERFORM A CONTROL CAVOGRAPHY. FAILURE TO ENGAGE THE HOOK WAS DEFINED AS LONG DURING UNSUCCESSFUL ATTEMPTS WITH MULTIPLE PRE-SHAPED CATHETERS AND DIFFERENT SNARE SIZES. INABILITY TO SHEATHE THE FILTER WAS DEFINED AS INABILITY TO ADVANCE THE SHEATH OVER THE ENGAGED HOOK AND FILTER-EITHER BECAUSE THE PATIENT COMPLAINED OF PAIN OR UNACCEPTABLE FORCE WOULD HAVE TO BE APPLIED ON THE SHEATH AND SNARE. IN THESE SITUATIONS, THE FILTERS WERE UNSHEATHED AND UNHOOKED AND LEFT IN PLACE AS A PERMANENT DEVICE. EXCEPT FOR ONE PATIENT, OTHER TECHNIQUES TO MOVE OR CHANGE THE FILTER POSITION WERE NOT PERFORMED. RIMON, URI ET AL (2010 JUNE 10) OPTEASE VENA CAVA FILTER OPTIMAL INDWELLING TIME AND RETRIEVABILITY. CARDIOVASCULAR INTERVENTIONAL RADIOLOGY (2011) 34:532-535. PLEASE NOTE THAT THE FOLLOWING FOUR SERVICE REQUESTS ARE RELATED TO THIS THE SAME EVENT OF INABILITY TO ENGAGE THE FILTER HOOK DURING RETRIEVAL OF THE DEVICE AND ARE BEING REPORTED TO THE FDA: (B)(4). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT FROM A JOURNAL ARTICLE (DOTAN ET AL IN OPTEASE VENA CAVA FILTER OPTIMAL INDWELLING TIME AND RETRIEVABILITY CARDIOVASC INTERVENT RADIOL (2011)) STATES THAT THERE WAS INABILITY TO ENGAGE THE FILTER HOOK DURING RETRIEVAL OF THE DEVICE. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE INDWELLING TIME AND RETRIEVABILITY OF THE OPTEASE IVC FILTER. BETWEEN 2002 AND 2009, A TOTAL OF 811 OPTEASE FILTERS WERE INSERTED: 382 FOR PROPHYLAXIS IN MULTITRAUMA PATIENTS AND 429 FOR PATIENTS WITH VENOUS THROMBO-EMBOLIC (VTE) DISEASE. IN 139 PATIENTS [97 MEN AND 42 WOMEN; MEAN AGE, 36 (RANGE, 17-82) YEARS], FILTER RETRIEVAL WAS ATTEMPTED. FROM (B)(6) 2002 TO (B)(6) 2009, 811 OPTEASE FILTERS WERE INSERTED IN A SINGLE TERTIARY CARE INSTITUTION: 382 FILTERS FOR PROPHYLAXIS IN MULTITRAUMA PATIENTS, AND 429 FOR PATIENTS WITH VTE DISEASE, WHO WERE ANTICOAGULATION TREATMENT FAILURES OR WHO HAD CONTRAINDICATIONS TO ANTICOAGULATION. FILTERS INSERTED AS A PROPHYLAXIS IN TRAUMA PATIENTS WERE INTENDED TO BE RETRIEVED IN ALL PATIENTS YOUNGER THAN AGE 60 YEARS. THE PHYSICIANS ARBITRARILY DECIDED NOT TO RETRIEVE FILTERS IN PATIENTS OLDER THAN THIS AGE UNLESS THE PATIENT HAS NO OTHER SIGNIFICANT DISEASES. A TOTAL OF 164 PATIENTS WERE REFERRED FOR FILTER REMOVAL, WHILE THERE WAS NO LONGER A NEED FOR IT NOR WAS THERE ANY MORE CONTRAINDICATION FOR ANTICOAGULATION. ANTICOAGULATION THERAPY WAS GIVEN ONLY TO THOSE PATIENTS WITH PROVEN VTE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1