BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER

    MDR report key: 3205066 · Received July 1, 2013

    Report

    Report Number
    3003862657-2013-00004
    Event Type
    Other
    Date Received
    July 1, 2013
    Date of Event
    March 14, 2013
    Report Date
    June 28, 2013
    Manufacturer
    REX MEDICAL LP
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: REQUEST/ REVIEW OF PRODUCT IN QUESTION FOR EVALUATION; CASE IMAGE, VIDEOS, ETC. TO BE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS NOT RETURNED TO FOR EVALUATION. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION PERFORMED FOR THIS LOT NO. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS PRODUCT COMPLAINT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION PROVIDED TO REX MEDICAL FOR INVESTIGATION. THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION; THERE WERE NO CASE IMAGES OR VIDEOS PROVIDED FOR REVIEW.

    Description of Event or Problem · 1

    AS REPORTED TO REX MEDICAL VIA E-MAIL FROM (B)(4) IN THE FORM OF MEDWATCH FORM FDA 3500A THAT WAS FILED BY (B)(6) HOSPITAL: AN IVC FILTER WAS PLACED IN THE PATIENT IN LATE SPRING OF 2012. DURING RETRIEVAL PROCEDURE NEARLY A YEAR LATER, THE FILTER HOOK FRACTURED. THE RETRIEVAL WAS A DIFFICULT ONE, THE FILTER WAS TILTED LEFT AND THE LEGS WERE INTEGRATED INTO THE IVC WALL. HYPERPLASIA WAS NOTED AT THE HEAD OF THE FILTER. FILMS PERFORMED AFTER THE RETRIEVAL DID NOT SHOW A RETAINED FOREIGN OBJECT. THE RETRIEVAL TEAM BELIEVES THAT FRAGMENT WAS REMOVED AND LOST IN THE DRAPES. UNLIKELY THERE WAS PATIENT HARM. STILL THE FILTER DID FRACTURE DURING THE RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297531 OPTION RETRIEVABLE VENA CAVA FILTER VENA CAVA FILTER DTK REX MEDICAL LP 352506070 S37084

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other