BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5309515 · Received December 18, 2015

    Report

    Report Number
    3002808486-2015-00180
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Report Date
    November 25, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REFERRED TO HAVE BEEN IMPLANTED IN 2000, BUT THE COOK CELECT FILTER WAS NOT ON THE MARKET IN 2000. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K11057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT PER IMAGE IT IS CONSIDERED TO BE A COOK CELECT FILTER. LOT# IS UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. REFERRED TO HAVE BEEN IMPLANTED IN (B)(6) 2008. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815 OR K073374. SUMMARY O INVESTIGATIONAL FINDINGS: REGARDING FILTER TILT: A MINIMAL DEGREE OF 3 DEGREES WAS OBSERVED ON THE IMAGING. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. REGARDING FILTER LEG FRACTURE: THE RETURNED IMAGING SHOWS A CELECT FILTER WITH ITS' HOOK TERMINATING IN THE MID T11 VERTEBRAL BODY. ONE PRIMARY LEG IS FRACTURED AND IS IDENTIFIED AT THE L3/L4 VERTEBRAL BODY LEVEL. IN THIS CASE PATIENT WAS ASYMPTOMATIC. RECEIVED IS A PHOTO OF A CELECT FILTER WITH A FRACTURED PRIMARY LEG AND ALL OTHER LEGS APPEAR INTACT. SOME TISSUE IS ADHERENT TO PARTS OF THE FILTER. THIS MAY REPRESENT FIBRINOUS TISSUE AND POSSIBLY ENDOTHELIALIZATION. FRACTURE OF THE WIRE IS A KNOWN RISK IN RELATION TO AN IMPLANTED FILTER AND REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. REGARDING IVC PERFORATION: IN THIS CASE THERE WAS, PRIOR TO EXPLANT, GRADE 3 INTERACTION OF ONE LEG WITH THE HEPATIC PARENCHYMA, AND ONE LEG WITH THE GRADE 3 INTERACTION WITH THE PANCREATIC PARENCHYMA. ONE PRIMARY LEG HAD GRADE 2 INTERACTION AS WELL AS ONE SECONDARY LEG. THE OTHER PRIMARY LEGS DO ALL APPEAR TO BE WITHIN THE LUMEN OF THE IVC. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. IN THIS CASE PATIENT WAS ASYMPTOMATIC. IN THIS CASE IT WAS NOTICED THAT THE FILTER LEG WAS MOST LIKELY WITHOUT RISK TO THE PATIENT AT THE TIME, AS IT WAS LOCATED IN THE PSOAS MUSCULATURE.. LOT AND RPN ARE UNKNOWN. 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 VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: A FEMALE PATIENT WITH DVT HAD A CONSULT WITH HER PHYSICIAN REGARDING HER IMPLANTED DEVICE. PER THE IMAGING IT WAS NOTED THAT THE FILTER HAD FRACTURED. THE PHYSICIAN HAS SCHEDULED A RETRIEVAL FOR (B)(6) 2015. THE DEVICE WAS INITIALLY IMPLANTED IN 2000. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: A FEMALE PATIENT WITH DVT HAD A CONSULT WITH HER PHYSICIAN REGARDING HER IMPLANTED DEVICE. PER THE IMAGING IT WAS NOTED THAT THE FILTER HAD FRACTURED. THE PHYSICIAN HAS SCHEDULED A RETRIEVAL FOR (B)(6) 2015. THE DEVICE WAS INITIALLY IMPLANTED IN 2000. ADDITIONAL INFORMATION RECEIVED: CONFIRMATION THAT THE FILTER HAD BEEN REMOVED. THE PHYSICIAN WAS ABLE TO GET THE FILTER OUT. THE FRACTURED STRUT WAS NOT ATTEMPTED TO BE RETRIEVED AT THE PHYSICIAN SAID IT WAS IN THE PSOAS MUSCLE. THE DISTRICT MANAGER FORWARDED THE IMAGING IN REFERENCE TO THIS AND STATED THAT IT APPEARS THAT THE FILTER HAS NOT HAD ANY MIGRATION. FILTER PLACED IN (B)(6) 2008 - SUPRARENAL PLACEMENT. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837753 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other