BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 2465989 · Received February 23, 2012

    Report

    Report Number
    9616099-2012-00111
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    August 6, 2011
    Report Date
    February 14, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROACH WAS UNDERTAKEN. AFTER INSTILLATION OF GENERAL ANESTHESIA TO THE PATIENT, SURGICAL CUTDOWN WAS PERFORMED IN THE RIGHT GROIN, WHEREUPON A 16FR SHEATH (CHECK-FLO PERFORMER; COOK MEDICAL, (B)(4)) WAS INSERTED INTO THE RIGHT COMMON FEMORAL ARTERY. PERCUTANEOUS ACCESS TO THE LEFT BRACHIAL ARTERY WAS GAINED THROUGH ULTRASONOGRAPHIC GUIDANCE, AND AN 8FR-LONG SHEATH (SUPER ARROW-FLEX; ARROW INTERNATIONAL, (B)(4)) WAS ADVANCED INTO THE ABDOMINAL AORTA TO A LEVEL PROXIMAL TO THE TRAPEASE FILTER. A DEFLECTABLE CATHETER (VENTURE; ST JUDE MEDICAL INC, (B)(4)) WAS USED TO HOOK THE SUPERIOR APEX OF THE FILTER. THROUGH THIS CATHETER, A 0.014-INCH GUIDEWIRE (PILOT 50; ABBOTT VASCULAR INC, (B)(4)) WAS INSERTED AND LOOPED THROUGH THE APEX OF THE FILTER (TOWARD THE 8FR SHEATH). THE FREE END OF THIS WIRE WAS THEN CAPTURED WITH A 25-MM GOOSENECK SNARE DEVICE (AMPLATZ; EV3, (B)(4)) AND PULLED OUT OF THE 8FR SHEATH SUCH THAT THE WIRE WAS HOOKED AROUND THE APEX AND BOTH ENDS OF THE WIRE WERE EXITING THE BRACHIAL SHEATH. FROM THE FEMORAL ARTERY, A SIMILAR TECHNIQUE WAS USED. AN 11FR-LONG SHEATH (SUPER ARROW-FLEX; ARROW (B)(4)) WAS PLACED THROUGH THE 16FR SHEATH. A VENTURE CATHETER WAS USED TO HOOK THE INFERIOR ASPECT OF THE FILTER AND A 0.014-INCH PILOT 150 WIRE WAS ADVANCED THROUGH THE CATHETER UP AND OVER THE APEX POINTING IN THE CAUDAD DIRECTION. THIS PORTION OF THE PROCEDURE WAS TECHNICALLY DEMANDING, AND ALTHOUGH WE ATTEMPTED TO HOOK THE APEX OF THE FILTER, A STRUT IN THE LOWER HALF OF THE FILTER WAS HOOKED. THE FREE END OF THE WIRE WAS CAPTURED USING A 25-MM AMPLATZ GOOSENECK SNARE AND PULLED THROUGH THE 11FR SHEATH. BOTH ENDS OF THE WIRE WERE THEN EXITING THE 11FR SHEATH FROM THE FEMORAL ARTERY. AFTER THE WIRES WERE SECURED TO THE SUPERIOR AND INFERIOR ASPECTS OF THE FILTER, GENTLE RETRACTION WAS HELD ON THE WIRES FROM ABOVE AND BELOW IN AN EFFORT TO ELONGATE THE FILTER, RELEASE THE BARBS FROM THE WALL OF THE AORTA, AND PREVENT MOVEMENT. AS TENSION WAS PLACED PROXIMAL AND DISTAL CONCOMITANTLY, THE FILTER SPRUNG SHUT AND COLLAPSED. WITH TRACTION MAINTAINED, THE 8FR SHEATH WAS ADVANCED OVER THE FILTER, COVERING THE SUPERIOR STRUTS. THE 11FR SHEATH WAS ADVANCED OVER THE 8FR SHEATH IN AN INTUSSUSCEPTION MANNER. FROM BELOW, THE FILTER AND ALL WIRES WERE REMOVED. THE FILTER WAS EXAMINED ON THE OPERATING TABLE. A PIGTAIL CATHETER WAS PLACED FROM THE BRACHIAL APPROACH AND DIGITAL SUBTRACTION ANGIOGRAPHIC IMAGING PERFORMED. AFTER THE PROCEDURE, THE PATIENT HAD SYMPTOMS OF LEFT ARM PAIN AND PARESTHESIAS WITH DIMINISHED DISTAL PULSES. HE REQUIRED SURGICAL EXPLORATION FOR REMOVAL OF THROMBUS AT THE PUNCTURE SITE. HE SUBSEQUENTLY HAD RECOVERY OF BLOOD FLOW TO THE HAND AND HAD AN UNEVENTFUL POSTOPERATIVE CONVALESCENCE. THE PATIENT WAS TREATED WITH CLOPIDOGREL FOR 3 MONTHS POSTOPERATIVELY. NAIDU ET AL IN ENDOVASCULAR RETRIEVAL OF A TRAPEASE PERMANENT INFERIOR VENA CAVA FROM THE AORTA; J VASC SURG. 2012 JAN;55(1):237-9. DOI:10.1016/J.JVS.2011.05.090; DESCRIBE A CASE IN WHICH A PERMANENT VENA CAVAL FILTER WAS INADVERTENTLY PLACED IN THE INFRARENAL AORTA AND WAS RETRIEVED WITH ENDOVASCULAR TECHNIQUES 4 WEEKS LATER. THE OPERATOR RECOGNIZED THE INTRA-AORTIC PLACEMENT AND PROCEEDED TO PLACE AN ADDITIONAL FILTER IN THE INFRARENAL IVC. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED WAS CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE. PLEASE NOTE THAT THE EXACT IMPLANT DATE AND THE DATE OF THE RETRIEVAL PROCEDURE ARE NOT KNOWN. THE EVENT DATE USED IN THE DATE OF PUBLICATION.

    Description of Event or Problem · 1

    NAIDU ET AL IN ENDOVASCULAR RETRIEVAL OF A TRAPEASE PERMANENT INFERIOR VENA CAVA FROM THE AORTA; J VASC SURG. 2012 JAN;55(1):237-9. DOI:10.1016/J.JVS.2011.05.090; DESCRIBE A CASE IN WHICH A PERMANENT VENA CAVAL FILTER WAS INADVERTENTLY PLACED IN THE INFRARENAL AORTA AND WAS RETRIEVED WITH ENDOVASCULAR TECHNIQUES 4 WEEKS LATER. A (B)(6) MAN WAS REFERRED FOR CONSULTATION REGARDING A PERMANENT INFERIOR VENA CAVA (IVC) FILTER THAT WAS PLACED WITHIN THE AORTA AT AN OUTSIDE INSTITUTION. SIX WEEKS EARLIER, THE PATIENT WAS IN A BIKING ACCIDENT THAT RESULTED IN UPPER AND LOWER EXTREMITY INJURIES. HE WAS WHEELCHAIR BOUND AND HAD A DEEP VENOUS THROMBOSIS IN THE LEFT LOWER EXTREMITY 2 WEEKS AFTER THE ACCIDENT. BECAUSE OF HIS EXTENSIVE INJURIES AND THE POTENTIAL RISK OF PULMONARY EMBOLI, AN IVC FILTER WAS PLACED. DETAILS OF THE INSERTION FROM THE OUTSIDE FACILITY WERE NOT AVAILABLE; HOWEVER, IMAGING AT THE TIME OF PLACEMENT SHOWED THAT THE FILTER WAS PLACED INADVERTENTLY IN THE INFRARENAL AORTA. THE OPERATOR RECOGNIZED THE INTRA-AORTIC PLACEMENT AND PROCEEDED TO PLACE AN ADDITIONAL FILTER IN THE INFRARENAL IVC. THE INFORMATION GIVEN TO THE PATIENT SHOWED THAT THE FILTER WAS A NONRETRIEVABLE (PERMANENT) VENA CAVAL FILTER (TRAPEASE; CORDIS CORP, (B)(4)). AFTER THE PROCEDURE, THE PATIENT RECEIVED ANTICOAGULATION TREATMENT WITH WARFARIN. HE PRESENTED TO OUR INSTITUTION 4 WEEKS AFTER FILTER PLACEMENT. HE HAD NO CLAUDICATION SYMPTOMS AND NO EVIDENCE OF ONGOING VENOUS THROMBOSIS. REMOVAL OF THE INTRAAORTIC FILTER WAS BELIEVED TO BE PRUDENT GIVEN THE POTENTIAL RISK OF THROMBOEMBOLIC COMPLICATIONS FROM THE FILTER AND THE YOUNG, ACTIVE STATUS OF THE PATIENT. TREATMENT OPTIONS INCLUDED OBSERVATION WITH ANTICOAGULATION (WARFARIN OR OTHER ANTIPLATELET THERAPY), OPEN FILTER REMOVAL, OR ENDOVASCULAR FILTER RETRIEVAL. ALTHOUGH THE FILTER IS DESIGNED TO BE NONRETRIEVABLE, A CAUTIOUS ATTEMPT AT RETRIEVAL WAS BELIEVED TO BE THE BEST OPTION AND...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE FILTER THROMBECTOMY SYSTEMS (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R