BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 4054079 · Received August 26, 2014

    Report

    Report Number
    1820334-2014-00398
    Event Type
    Injury
    Date Received
    August 26, 2014
    Date of Event
    January 9, 2013
    Report Date
    August 4, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # IS UNK; HOWEVER, COULD BE EITHER K072240 OR K043509. EVENT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION IS BASED SOLELY ON EVENT DESCRIPTION, SINCE NO DEVICE OR IMAGING HAVE BEEN AVAILABLE FOR EXAMINATION. IT IS UNK WHEN THE GUNTHER TULIP FILTER WAS IMPLANTED AND ALSO THE PT'S MEDICAL HISTORY. DURING THE COURSE OF INVESTIGATION, A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (M), QUALITY CONTROL (QC), SPECIFICATIONS, AND TRENDS WAS CONDUCTED. NO EVIDENCE TO SUGGEST DEVICE FAILURE BASED ON INFORMATION PROVIDED. IT IS COOK'S EXPERIENCE THAT FRACTURE IS SECONDARY TO PERFORATION OF IVC. FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK. SEVERAL CASE REPORTS IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. CHANGES TO THE FILTER CONFIGURATION AND TO THE FILTER PLACEMENT, IS KNOWN TO CAUSE STRESS AND POSSIBLY FRACTURE TO THE FILTER WIRES DUE TO E.G. RESPIRATORY MOVEMENTS. ALSO SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD ALSO CONTRIBUTE TO CHANGE IN FILTER CONFIGURATION. FRACTURE OF THE WIRE IS AN UNCOMMON, BUT KNOWN RISK IN RELATION TO FILTER IMPLANT. A REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE: IN POTENTIAL ADVERSE EVENTS ARE MENTIONED- DAMAGE TO THE VENA CAVA, PULMONARY EMBOLISM, FILTER EMBOLIZATION, VENA CAVA PERFORATION, VENA CAVA OCCLUSION OR THROMBOSIS, HEMORRHAGE, HEMATOMA AT VASCULAR ACCESS SITE, INFECTION AT VASCULAR ACCESS SITE, DEATH. BASED ON THE LIMITED INFORMATION PROVIDED, THE EXACT ROOT CAUSE FOR WHAT CAUSED THE FILTER FRACTURE AND DIFFICULT RETRIEVAL CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR THE DEVICE. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA), NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A PT UNDERWENT A GUNTHER TULIP FILTER RETRIEVAL ON (B)(6) 2013 AT HOSPITAL 2 (HUP). THE PHYSICIAN INDICATED THE FILTER HAD FRACTURED AND THAT THE RETRIEVAL HAD FAILED AT HOSPITAL 1 BECAUSE THE HOOK OR LEGS WERE EMBEDDED; BUT INTACT. THE DEVICE WAS SUCCESSFULLY REMOVED INTACT AT HOSPITAL 2. COOK REP IS TRYING TO GET ADDITIONAL INFO. INFO NOT PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    IT IS UNK IF THE PT UNDERWENT ANY ADDITIONAL PROCEDURES OR ANY ADVERSE EFFECTS AT THIS TIME. INFORMATION HAS BEEN REQUESTED BUT NONE HAVE BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518297 UNK DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Other