BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 4687019 · Received April 13, 2015

    Report

    Report Number
    3002808486-2015-00036
    Event Type
    Injury
    Date Received
    April 13, 2015
    Date of Event
    August 18, 2014
    Report Date
    August 21, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI#: (B)(4). EVALUATION IS BASED ON THE DESCRIPTION OF THE EVENT AND THE CORE LAB FINDINGS. FILTER REMOVAL WAS PLANNED (B)(6) 2014 SINCE THE FILTER WAS NO LONGER NEEDED. FILTER REMOVAL WAS THEN PERFORMED (B)(6) 2014 AND ON THIS DAY THE PERFORATION WAS OBSERVED. HIGHEST GRADE OF PERFORATION WAS THREE (TWO FILTER LEGS). CORE LAB NOTED THAT THE RIGHT SIDED PE HAD RESOLVED. THERE WAS NO EVIDENCE OF FILTER EMBOLIZATION. FILTER TILT WAS 2.2 DEGREES IN THE SAGITTAL PLANE AND 6.2 DEGREES IN THE CORNEAL PLANE. THERE WERE NO LEGS WITH GRADE 0 INTERACTION WITH THE IVC WALL, SIX WITH GRADE 1, AND FOUR WITH GRADE 2. THERE WAS NO HEMORRHAGE, HEMATOMA, OR OTHER CLINICAL FINDING OBSERVED AT THE SITE OF THE INTERACTION WITH THE ICV WALL. THERE WERE TWO LEGS WITH GRADE 3 INTERACTION WITH THE IVC WALL. THE DUODENUM AND LUMBAR VEIN WERE AFFECTED. THERE WAS NO HEMORRHAGE, HEMATOMA, OR OTHER CLINICAL FINDING OBSERVED AT THE SITE OF THE INTERACTION WITH THE IVC WALL. PERFORATION OF VENA CAVA BY FILTER LEG IS ADDRESSED IN THE PRODUCT'S IFU AS A POTENTIAL ADVERSE EVENT. THE EXACT ROOT CAUSE FOR WHAT CAUSED THE FILTER PERFORATION IS UNK. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK AND HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    POST MARKET STUDY: ON (B)(6) 2014 (101 DAYS POST-PROCEDURE), THE PRE-RETRIEVAL CT WAS PERFORMED. THE CT REVEALED NO PE. HIGHEST GRADE OBSERVED OF FILTER LEG INTERACTION WITH ICV WALL WAS THREE (DEFINITION OF GRADE 3 AS FOLLOWS, "FILTER STRUT IS TOUCHING, IMPRESSING, OR PERFORATING ANOTHER ORGAN (E.G., LIVER, BOWEL, AORTA, PSOAS MUSCLE, VERTEBRAL BODY, LYMPH NODES))". THERE WERE NO CLINICAL SEQUELAE ASSOCIATED WITH THIS IMAGING. THE IMAGING RESULTS DID NOT LEAD TO AN INTERVENTION. THE RETRIEVAL WAS NOT CANCELLED DUE TO THE IMAGING RESULTS. ON (B)(6) 2014 (109 DAYS POST-PROCEDURE), THE FILTER RETRIEVAL PROCEDURE WAS PERFORMED. THE IVC FILTER WAS NO LONGER CLINICALLY NEEDED. PRIOR TO THE PROCEDURE, THE PT WAS ON PROPHYLACTIC LMW HEPARIN. THERE WAS NO THROMBUS PRESENT IN THE FILTER. A FILTER LEG(S) APPEARED OUTSIDE THE COLUMN OF CONTRAST. THE FILTER WAS RETRIEVED ENDOVASCULARLY USING A GUNTHER TULIP RETRIEVAL SET VIA THE RIGHT INTERNAL JUGULAR VEIN. THERE WAS NO DIFFICULTY IN ATTEMPTING OT RETRIEVE THE FILTER. THERE WAS NO EXTRAVASATION OF CONTRAST AFTER FILTER RETRIEVAL. THE PT WILL BE FOLLOWED ACCORDING TO THE PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244596 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3157422

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening