BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2775177 · Received October 7, 2012

    Report

    Report Number
    9616099-2012-00571
    Event Type
    Injury
    Date Received
    October 7, 2012
    Date of Event
    April 1, 2007
    Report Date
    September 13, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH: KELLER ET AL. CLINICAL COMPARISON OF TWO OPTIONAL VENA CAVA FILTERS. JOURNAL OF VASCULAR INTERVENTIONAL RADIOLOGY 2007; 18:505'511; REPORT IN THE RESULTS OF A COMPARISON STUDY BETWEEN THE GUNTHER TULIP AND OPTEASE FILTER. ONE PATIENT HAD LATE CAVAL THROMBOSIS IN THE OPTEASE GROUP. FIVE OPTEASE FILTERS HAD TO BE REMOVED WITH MANIPULATIONS VIA AN ADDITIONAL ACCESS BECAUSE THE HOOKLET COULD NOT BE ENGAGED. TWENTY-ONE OPTEASE FILTERS WERE ASSOCIATED WITH MINOR THROMBOSIS. IN FOUR OF THE 80 PATIENTS WITH OPTEASE FILTERS, FILTER RETRIEVAL WAS DELAYED BECAUSE OF EXTENSIVE FILTER THROMBOSIS. ONE OPTEASE FILTER WAS INADVERTENTLY PLACED WITH ITS CAUDAL END JUST AT THE ILIAC VENOUS CONFLUENCE AND COULD NOT BE RETRIEVED VIA THE RIGHT FEMORAL VEIN USED FOR FILTER INTRODUCTION BECAUSE THE FILTER HAD SLIGHTLY MIGRATED IN THE CAUDAL DIRECTION BUT WAS RETRIEVED. THERE WAS PE FOUND IN FIVE PATIENTS. IN ONE PATIENT WITH MULTIPLE TRAUMAS WHO HAD RECEIVED AN OPTEASE FILTER FOR PE PROPHYLAXIS, BILATERAL SUB SEGMENTAL PE WAS SEEN AT CT ANGIOGRAPHY ALONG WITH 75% DIAMETER THROMBOSIS OF THE FILTER 12 DAYS AFTER FILTER PLACEMENT. THE PATIENT WAS ASYMPTOMATIC. TWO PATIENTS WITH OPTEASE FILTERS HAD A SYMPTOMATIC PE AFTER FILTER RETRIEVAL. BOTH WERE PATIENTS WITH MULTIPLE TRAUMA WHOSE CONTRAINDICATION TO ANTICOAGULATION PERIOD HAD ELAPSED. THE NEW PES WERE CONFIRMED WITH CT ANGIOGRAPHY. IN ONE PATIENT, THE PE WAS DIAGNOSED 5 DAYS AFTER COMPLICATION FREE FILTER REMOVAL. IN THE OTHER PATIENT, THE PE OCCURRED 2 HOURS AFTER REMOVAL OF A FILTER CONTAINING MINOR THROMBOTIC MATERIAL. THESE PATIENTS RECEIVED A SECOND IVC FILTER ON THE SAME DAY OF AND 2 DAYS AFTER THESE EMBOLIC EVENTS, RESPECTIVELY. BOTH SECOND FILTERS WERE REMOVED WITHOUT FURTHER COMPLICATIONS. TWO FILTERS WERE NOT RETRIEVED BECAUSE OF A MAJOR BLOOD CLOT IN THE FILTER, WHICH OCCLUDED THREE-FOURTHS OF THE IVC DIAMETER. THE DATE OF IMPLANTATION FOR THESE EVENTS IS UNKNOWN. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF THIRTY-NINE (39) SEPARATE EVENTS INVOLVING THE OPTEASE FILTER IN THE SAME LITERATURE ARTICLE: ONE (1)-LATE CAVAL THROMBOSIS; FIVE (5)-REMOVAL DIFFICULTY/BUT REMOVED; TWENTY-ONE (21)-MINOR THROMBOSIS; SIX (6)-EXTENSIVE THROMBOSIS; ONE (1) MIGRATION; AND FIVE (5)-PULMONARY EMBOLISM FROM A LITERATURE REVIEW SOURCE AND FOR WHICH SPECIFIC PATIENT INFORMATION WAS NOT AVAILABLE. AN INVESTIGATION IS UNDERWAY TO OBTAIN THIS INFORMATION. THE PRODUCTS ARE NOT AVAILABLE FOR EVALUATION AND TESTING. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE 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. VENA CAVA THROMBOSIS. DVT OCCURS WHEN A BLOOD CLOT FORMS IN A DEEP VEIN AND IS MOST COMMON IN THE DEEP VEINS OF YOUR LOWER LEG (CALF), AND CAN SPREAD UP TO THE VEINS IN YOUR THIGH. DVT CAN ALSO FIRST DEVELOP IN THE DEEP VEINS IN YOUR THIGH AND, MORE RARELY, IN OTHER DEEP VEINS, SUCH AS THE ONES IN YOUR ARM. DEEP VEIN THROMBOSIS IS THE RESULT OF THREE PRINCIPAL FACTORS : 1. REDUCED OR STAGNANT BLOOD FLOW IN DEEP VEINS (VENOUS STASIS). 2. INJURY TO THE BLOOD VESSEL WALL. 3. AN INCREASE IN THE ACTIVITY OF THOSE SUBSTANCES IN THE BLOOD THAT ARE PART OF THE NORMAL CLOTTING MECHANISM, A CONDITION CALLED HYPERCOAGULABILITY (WHICH MEANS A MORE ACTIVE CLOTTING STATE). PLACEMENT OF A VENA CAVA FILTER IS NOT A CURE FOR DVT NOR DOES IT PREVENT THE FORMATION OF DVT. INFERIOR VENA CAVA FILTERS ARE USED TO PREVENT SEQUELAE, ESPECIALLY PE, IN PATIENTS WITH CONTRAINDICATIONS TO, COMPLICATIONS OF, OR FAILURE OF ANTICOAGULATION THERAPY AND PATIENTS WITH EXTENSIVE FREE-FLOATING THROMBI OR RESIDUAL THROMBI FOLLOWING MASSIVE PE. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. THERE IS NO MEDICAL EVIDENCE OF A CAUSAL RELATIONSHIP BETWEEN THE VENA CAVA FILTER AND THE FORMATION OF NEW DVT. VARIOUS COMPLICATIONS HAVE BEEN REPORTED WITH USE OF RETRIEVABLE IVC FILTERS. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL IMPOSSIBLE. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. INCORRECT ORIENTATION OF THE FILTER IS A KNOWN COMPLICATION FOR FILTER PLACEMENT AS INDICATED IN THE IFU. THE TIMING AND MECHANISM OF THE FILTER TILT REMAINS UNCERTAIN. THE OPTEASE RETRIEVABLE FILTER IS CONSIDERED A PERMANENT IMPLANT IF IT IS NOT RETRIEVED WITHIN THE SPECIFIED TIME PERIOD. VARIOUS COMPLICATIONS HAVE BEEN REPORTED WITH USE OF RETRIEVABLE IVC FILTERS. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL IMPOSSIBLE. IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THROMBUS IN THE FILTER DOES NOT REPRESENT A DEVICE MALFUNCTION. THROMBOSIS IN THE FILTER IS A WELL KNOWN POTENTIAL COMPLICATION AND OCCURS IN APPROXIMATELY 3.6 TO 11.2 % OF ALL PATIENTS. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. IVC FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE IFU AS SUCH. INTRACARDIAC MIGRATION OF IVC FILTERS IS A RARE BUT POTENTIALLY FATAL EVENT. POSSIBLE CAUSES FOR FILTER MIGRATION INCLUDES MEGA CAVA (IVC DIAMETER >28 MM), WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, SAIL EFFECT OF LARGE CLOT BURDEN WITHIN THE FILTER, MECHANICAL DEVICE FAILURE, AND OPERATOR ERROR. SOME STUDIES SUGGEST THAT STRENUOUS PHYSICAL ACTIVITY AND INCREASED INTRA-ABDOMINAL PRESSURE CAN LEAD TO THE FRACTURE AND MIGRATION OF IVC FILTERS. MIGRATION OF IVC FILTERS HAS BEEN DEMONSTRATED WHEN THE PRESENCE OF AN OVERBURDEN OF THROMBUS IN THE VASCULATURE OCCURS THAT EXCEEDS THE DEVICES ABILITY TO EXERT RADIAL FORCE TOWARD THE VESSEL WALLS AND MAINTAIN OPTIMAL POSITIONING. THERE IS NOT ENOUGH INFORMATION TO DRAW A DEFINITIVE CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. INFERIOR VENA CAVA FILTERS ARE USED TO PREVENT PE IN PATIENTS WITH CONTRAINDICATIONS TO, COMPLICATIONS OF, OR FAILURE OF ANTICOAGULATION THERAPY AND PATIENTS WITH EXTENSIVE FREE-FLOATING THROMBI OR RESIDUAL THROMBI FOLLOWING MASSIVE PE. CURRENT EVIDENCE INDICATES THAT IVC FILTERS ARE LARGELY EFFECTIVE; BREAKTHROUGH PE OCCURS IN ONLY 0% TO 6.2% OF CASES. CONTRAINDICATIONS TO IMPLANTATION OF IVC FILTERS INCLUDE LACK OF VENOUS ACCESS, CAVAL OCCLUSION, UNCORRECTABLE COAGULOPATHY, AND SEPSIS. COMPLICATIONS INCLUDE MISPLACEMENT OR EMBOLIZATION OF THE FILTER, VASCULAR INJURY OR THROMBOSIS, PNEUMOTHORAX, AND AIR EMBOLI. RECURRENT PE, IVC THROMBOSIS, FILTER MIGRATION, FILTER FRACTURE, OR PENETRATION OF THE CAVAL WALL SOMETIMES OCCUR WITH LONG-TERM USE. THIS IS ONE OF SIX REPORTS FROM THE SAME LITERATURE ARTICLE: 9616099-2012-00568; 9616099-2012-00569; 9616099-2012-00570; 9616099-2012-00571; 9616099-2012-00572; 9616099-2012-00573.

    Additional Manufacturer Narrative · 1

    THE EVENT DATE IS BEING REPORTED AS (B)(6) 2007. THE DATE OF IMPLANTATION IS UNKNOWN/UNK. THIS REPORT REPRESENTS SIX (6) EVENTS OF (EXTENSIVE) THROMBOSIS WITHIN THE DEVICE FROM THE SAME LITERATURE ARTICLE. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF THIRTY-NINE (39) SEPARATE EVENTS INVOLVING THE OPTEASE FILTER IN THE SAME LITERATURE ARTICLE: ONE (1)-LATE CAVAL THROMBOSIS; FIVE (5)-REMOVAL DIFFICULTY/BUT REMOVED; TWENTY-ONE (21)-MINOR THROMBOSIS; SIX (6)-EXTENSIVE THROMBOSIS; ONE (1) -MIGRATION; AND FIVE (5)-PULMONARY EMBOLISM FROM A LITERATURE REVIEW SOURCE AND FOR WHICH SPECIFIC PATIENT INFORMATION WAS NOT AVAILABLE. AN INVESTIGATION IS UNDERWAY TO OBTAIN THIS INFORMATION. THESE EVENTS WILL BE CAPTURED IN SIX (6) PRODUCT ISSUES/PI'S. THE PRODUCTS ARE NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF SIX REPORTS FROM THE SAME LITERATURE ARTICLE: 9616099-2012-00568; 9616099-2012-00569; 9616099-2012-00570; 9616099-2012-00571; 9616099-2012-00572; 9616099-2012-00573.

    Description of Event or Problem · 1

    AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH: KELLER ET AL. CLINICAL COMPARISON OF TWO OPTIONAL VENA CAVA FILTERS. JOURNAL OF VASCULAR INTERVENTIONAL RADIOLOGY 2007; 18:505-511; REPORT IN THE RESULTS OF A COMPARISON STUDY BETWEEN THE GUNTHER TULIP AND OPTEASE FILTER. ONE PATIENT HAD LATE CAVAL THROMBOSIS IN THE OPTEASE GROUP. FIVE OPTEASE FILTERS HAD TO BE REMOVED WITH MANIPULATIONS VIA AN ADDITIONAL ACCESS BECAUSE THE HOOKLET COULD NOT BE ENGAGED. TWENTY-ONE OPTEASE FILTERS WERE ASSOCIATED WITH MINOR THROMBOSIS. IN FOUR OF THE 80 PATIENTS WITH OPTEASE FILTERS, FILTER RETRIEVAL WAS DELAYED BECAUSE OF EXTENSIVE FILTER THROMBOSIS. ONE OPTEASE FILTER WAS INADVERTENTLY PLACED WITH ITS CAUDAL END JUST AT THE ILIAC VENOUS CONFLUENCE AND COULD NOT BE RETRIEVED VIA THE RIGHT FEMORAL VEIN USED FOR FILTER INTRODUCTION BECAUSE THE FILTER HAD SLIGHTLY MIGRATED IN THE CAUDAD DIRECTION BUT WAS RETRIEVED. THERE WAS PE FOUND IN FIVE PATIENTS. IN ONE PATIENT WITH MULTIPLE TRAUMA WHO HAD RECEIVED AN OPTEASE FILTER FOR PE PROPHYLAXIS, BILATERAL SUBSEGMENTAL PE WAS SEEN AT CT ANGIOGRAPHY ALONG WITH 75% DIAMETER THROMBOSIS OF THE FILTER 12 DAYS AFTER FILTER PLACEMENT. THE PATIENT WAS ASYMPTOMATIC. TWO PATIENTS WITH OPTEASE FILTERS HAD A SYMPTOMATIC PE AFTER FILTER RETRIEVAL. BOTH WERE PATIENTS WITH MULTIPLE TRAUMA WHOSE CONTRAINDICATION TO ANTICOAGULATION PERIOD HAD ELAPSED. THE NEW PES WERE CONFIRMED WITH CT ANGIOGRAPHY.

    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