BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6108802 · Received November 17, 2016

    Report

    Report Number
    3002808486-2016-01434
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    November 8, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN REFERRED TO AS A COOK 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 REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121629 OR K121057. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A CELECT FILTER WAS PLACED AND 23 MONTHS LATER, AFTER ONE ATTEMPTED ENDOVASCULAR RETRIEVAL, THE PATIENT PRESENTED FOR SURGICAL FILTER RETRIEVAL WITH BACK PAIN AND PROXIMAL FILTER MIGRATION. THERE WERE REPORTED GRADE 3 INTERACTIONS WITH THE IVC WALL WITH LEGS EXTENDING INTO THE DUODENUM, ILIUM, AND L4 VERTEBRAL BODY WITH A PSOAS ABSCESS PRESENT. BASED ON THE LIMITED INFORMATION IN THE ARTICLE AND SINCE ONLY DRAWINGS WERE PROVIDED TO SUPPORT THE EVENT DESCRIPTION THE REASON FOR FILTER MIGRATION AND PERFORATION CANNOT BE DETERMINED. HOWEVER, AFTER ONE UNSUCCESSFUL RETRIEVAL ATTEMPT THE FILTER WAS 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. 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 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 23 MONTHS. BACK PAIN; IVC PERFORATION; DUODENUM, ILEUM, AND L4 VERTEBRAL BODY PENETRATION; PSOAS ABSCESS FILTER RETRIEVED BY OPEN SURGICAL REMOVAL. PATIENT OUTCOME: OPEN SURGICAL FILTER REMOVAL.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: FILTER IMPLANTED FOR 23 MONTHS. BACK PAIN; IVC PERFORATION; DUODENUM, ILEUM, AND L4 VERTEBRAL BODY PENETRATION; PSOAS ABSCESS FILTER RETRIEVED BY OPEN SURGICAL REMOVAL. PATIENT OUTCOME: OPEN SURGICAL FILTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759793 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening