BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVERY FILTER

    MDR report key: 9851044 · Received March 18, 2020

    Report

    Report Number
    2020394-2020-01735
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    March 24, 2006
    Report Date
    March 18, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K031328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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: KALVA, S.P., ATHANASOULIS, C.A., FAN, C. ET AL. ¿RECOVERY¿¿ VENA CAVA FILTER: EXPERIENCE IN 96 PATIENTS. CARDIOVASC INTERVENT RADIOL 29, 559¿564 (2006). HTTPS://DOI.ORG/10.1007/S00270-005-0271-1.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF CARDIO VASCULAR AND INTERVENTIONAL RADIOLOGY TITLED " ¿¿RECOVERY TM¿¿ VENA CAVA FILTER: EXPERIENCE IN 96 PATIENTS " THAT AFTER FILTER PLACEMENT, 12 OF THE 96 PATIENTS HAD SIGNS AND SYMPTOMS OF PULMONARY EMBOLISM (PE). THE STATUS OF THE PATIENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313395 RECOVERY FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other