BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRUX VENA CAVA FILTER SYSTEM, FEMORAL

    MDR report key: 4934644 · Received July 21, 2015

    Report

    Report Number
    2939520-2015-00042
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K150262
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO VOLCANO POLICY. NO PHYSICAL PRODUCT INVESTIGATION WAS POSSIBLE AS THE DEVICE WAS DISCARDED AT THE HOSPITAL. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED ADVERSE EVENT. TO DATE, NO OTHER COMPLAINTS WERE REPORTED FOR THIS SAME ADVERSE EVENT WITHIN THIS LOT. WE WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS VIA COMPLAINT REVIEW MEETINGS AND TREND DATA.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN PERFORMED A PROPHYLACTIC PLACEMENT OF A CRUX FEMORAL FILTER FOR UPCOMING SPINAL SURGERY DUE TO PATIENT'S HISTORY OF CLOTTING. PRE AND POST PLACEMENT VENA CAVAGRAMS INDICATED THAT THE FILTER WAS SUCCESSFULLY DEPLOYED AND SECURE IN THE PATIENT. SOME "STREAMING" OF CONTRAST WAS NOTED ON THE POST-PLACEMENT CAVAGRAM JUST PROXIMAL TO THE FILTER. THE PATIENT SUBSEQUENTLY UNDERWENT SPINAL SURGERY (DATE UNKNOWN). POST-SURGERY, VOLCANO LEARNED THE PATIENT PRESENTED WITH RENAL IMPAIRMENT SECONDARY TO BILATERALLY THROMBOSED RENAL VEINS. THE PATIENT HAD THROMBUS EXTENDING FROM BOTH ILIAC VEINS, THROUGHOUT THE INFERIOR VENA CAVA, INCLUDING BOTH RENAL VEINS, AND COMPLETE THROMBOSIS OF THE FILTER. ADDITIONALLY, THE FILTER HAD MIGRATED SUPRA-RENALLY AND WAS LOCATED IN THE MOST PROXIMAL SEGMENT OF THE IVC. IT WAS REPORTED THROMBUS EXTENDED ABOVE THE FILTER AND INTO THE PATIENT'S RIGHT ATRIUM. THE PATIENT WAS STARTED ON A HEPARIN REGIMEN AND AN APPROPRIATE INTERVENTIONAL STRATEGY WAS DETERMINED. THE PATIENT UNDERWENT ANGIOVAC THROMECTOMY TO REMOVE ALL THROMBUS FROM THE FILTER WEBBING AND RIGHT ATRIUM. AT THIS POINT, A DECISION WAS MADE TO REMOVE THE FILTER. DURING REMOVAL, THE THROMBUS BURDEN BELOW THE FILTER EXCEEDED THE CAPACITY OF THE ANGIOVAC DEVICE, AND THE RESIDUAL THROMBUS MIGRATED INTO THE RIGHT PULMONARY ARTERY. THE PATIENT THEN UNDERWENT SURGICAL PULMONARY EMBOLECTOMY. THE OUTCOME OF THE PROCEDURE AND PATIENT'S CURRENT CLINICAL STATUS IS UNKNOWN.

    Description of Event or Problem · 1

    THIS ADVERSE EVENT WAS INITIALLY REPORTED TO VOLCANO AS A PROPHYLACTIC PLACEMENT OF A CRUX FEMORAL FILTER. SUBSEQUENTLY, VOLCANO RECEIVED NOTIFICATION VIA MEDWATCH REPORT UF (B)(4) FROM THE (B)(4) ON 08/03/2015. THIS REPORT PROVIDES CLARIFICATION TO THE SEQUENCE OF EVENTS. PER (B)(6) THE INTENDED PROCEDURE WAS A TEMPORARY IVC FILTER PLACEMENT TO PREVENT RECURRENT PULMONARY EMBOLISM. PATIENT HAD LOWER EXTREMITY DVT'S AND PULMONARY EMBOLISM PRIOR TO CRUX FILTER PLACEMENT. A MALE PATIENT POST SPINAL SURGERY DEVELOPED BILATERAL LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) WHILE HOSPITALIZED. ANTICOAGULATION WAS BEGUN BUT WAS DISCONTINUED WHEN BLEEDING FROM THE INCISION AND SPINAL HEMATOMA DEVELOPED. THE PATIENT WAS TRANSFERRED TO A TERTIARY HOSPITAL WHERE A CRUX IVC FILTER WAS PLACED INFRARENAL WITHOUT COMPLICATION. WHILE AMBULATING IN THE HOSPITAL, 6 DAYS LATER, THE PATIENT BECAME HYPOTENSIVE, TACHYCARDIC AND COMPLAINED OF INTERMITTENT CHEST PRESSURE. BILATERAL PE, LINEAR FILLING DEFECT IN THE SUPRAHEPATIC IVC AND SUPRA-RENAL MIGRATION OF THE CRUX FILTER WAS NOTED ON A CT SCAN AND NEAR COMPLETE OCCLUSION OF THE IVC AND BILATERAL ILIAC VEINS NOTED ON ULTRASOUND. FOLLOWING ANTICOAGULATION THE FILTER WAS RETRIEVED AND PARTIAL THROMBECTOMY COMPLETED WITH ANGIOVAC ASPIRATION INTERVENTION. CLINICAL DETERIORATION DUE TO PRESUMED DISTAL EMBOLIZATION LED TO PULSELESS ELECTRICAL ACTIVITY ARREST (PEA). THE PATIENT WAS EMERGENTLY TAKEN TO THE OPERATING ROOM AND MEDIAN STERNOTOMY FOR ACUTE PULMONARY EMBOLECTOMY WAS PERFORMED. PATIENT'S CONDITION IS GOOD. HE IS OUT OF REHABILITATION AND HAS BEEN SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470800 CRUX VENA CAVA FILTER SYSTEM, FEMORAL FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK VOLCANO CORPORATION CRUX 7024 VCF 0252 20030851

    Patients

    Seq Age Sex Outcome Treatment
    1 56.0 YR Hospitalization| L| R