BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVERY FILTER

    MDR report key: 9963749 · Received April 15, 2020

    Report

    Report Number
    2020394-2020-02725
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    February 1, 2008
    Report Date
    April 15, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DTK
    PMA / PMN Number
    K031328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. JOURNAL ARTICLE CITATION: VEROUX, M., TALLARITA, T., PENNISI, M., & VEROUX, P. (2008). LATE COMPLICATION FROM A RETRIEVABLE INFERIOR VENA CAVA FILTER WITH ASSOCIATED CAVAL, AORTIC, AND DUODENAL PERFORATION: A CASE REPORT. JOURNAL OF VASCULAR SURGERY, 48(1), 223¿225. DOI: 10.1016/J.JVS.2008.02.002.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF VASCULAR SURGERY TITLED " LATE COMPLICATION FROM A RETRIEVABLE INFERIOR VENA CAVA FILTER WITH ASSOCIATED CAVAL, AORTIC, AND DUODENAL PERFORATION: A CASE REPORT " THAT 2 YEARS AFTER FILTER PLACEMENT, A THORACOABDOMINAL COMPUTED ANGIOGRAPHY (CT) ANGIOGRAPHY CONFIRMED COMPLETE THROMBOSIS OF THE INFERIOR VENA CAVA (IVC) JUST ABOVE THE RENAL VEIN. THE FILTER'S HOOK PERFORATED THE IVC WALL INTO RETROPERITONEUM, DUODENUM, AND AORTA WITH MURAL THROMBUS. THEREFORE, THE PATIENT UNDERWENT ABDOMINAL EXPLORATION; THE STRUT WAS REMOVED FROM DUODENUM AND PERFORATION WAS CLOSED BY SIMPLE SUTURE. IVC DISSECTION AND THROMBECTOMY OF THE AORTA, ILIAC VEIN AND IVC WAS PERFORMED AND THE AORTOTOMY WAS SUTURED, THE EXTRACTION OF FILTER WAS DIFFICULT AS THE PRONGS WERE INCLUDED INTO IVC WALL. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNEVENTFUL AND REMAINED SYMPTOM FREE AT 6 MONTH FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426833 RECOVERY FILTER VENA CAVA FILTER DTK BARD ACCESS SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR