BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6108803 · Received November 17, 2016

    Report

    Report Number
    3002808486-2016-01435
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    November 8, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS AF CELECT FILTER. . SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121629 OR K121057. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG #: UNKNOWN BUT REFERRED TO AS AF CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG # IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121629 OR K121057. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: A CELECT FILTER WAS PLACED IN A SUPRARENAL LOCATION AND 33 MONTHS LATER, THE FILTER HAD MIGRATED AND DEVELOPED SIGNIFICANT RIGHTWARD TILT. ALSO, THERE WAS FRACTURE OF AT LEAST 2 OF THE FILTER TINES WITH DISTAL EMBOLIZATION OF 1 OF THE LEGS INTO THE LUNG AND THE OTHER WITHIN THE L2 VERTEBRAL BODY. BASED ON THE LIMITED INFORMATION AND THE IMAGING PROVIDED THE REASON FOR FILTER MIGRATION, TILT, PERFORATION, AND FRACTURE CANNOT BE DETERMINED. HOWEVER, AFTER ONE UNSUCCESSFUL RETRIEVAL ATTEMPT THE FILTER AND THE FRACTURED LEGS WERE SURGICALLY REMOVED. FILTER MIGRATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. CRANIAL (INCLUDING TO THE HEART AND LUNGS) AND CAUDAL MIGRATIONS HAVE BEEN REPORTED. AMONG OTHER CAUSES, MIGRATION MAY BE ASSOCIATED WITH FILTER PLACEMENT IN IVCS WITH DIAMETERS OTHER THAN THOSE SPECIFIED IN THE INSTRUCTIONS FOR USE, IMPROPER DEPLOYMENT, DEPLOYMENT INTO CLOTS, DISLODGEMENT DUE TO LARGE CLOT BURDENS, AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. FILTER FRACTURE IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. FRACTURE OF A FILTER LEG CAN BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL STRESSED POSITION. AMONG OTHER CAUSES, FILTER FRACTURE MAY BE ASSOCIATED WITH A FILTER LEG PERFORATING THE IVC, A FILTER LEG BEING CAUGHT IN A SIDE BRANCH (E.G. RENAL VEIN), EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G. A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND / OR PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. IT HAS BEEN REPORTED THAT RETRIEVAL OF A FRACTURED FILTER OR FILTER FRAGMENTS USING ENDOVASCULAR TECHNIQUES IS POSSIBLE. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: FILTER IMPLANTED FOR 33 MONTHS. BACK PAIN; IVC AND RENAL VEIN PERFORATION; FRACTURE WITH TINE IN LUNG; FRACTURED TINE IN L2 VERTEBRAL BODY FILTER RETRIEVED BY OPEN SURGICAL REMOVAL. PATIENT OUTCOME: FRACTURED STRUTS RETRIEVED. OPEN SURGICAL FILTER REMOVAL.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: FILTER IMPLANTED FOR 33 MONTHS. BACK PAIN; IVC AND RENAL VEIN PERFORATION; FRACTURE WITH TINE IN LUNG; FRACTURED TINE IN L2 VERTEBRAL BODY FILTER RETRIEVED BY OPEN SURGICAL REMOVAL. PATIENT OUTCOME: FRACTURED STRUTS RETRIEVED. OPEN SURGICAL FILTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759958 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening