BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4089579 · Received September 15, 2014

    Report

    Report Number
    9616099-2014-00593
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 1, 2013
    Report Date
    August 24, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. THE CITATION IS AS FOLLOWS: WOODHOUSE J.B., UBEROI, R (2013, AUGUST). TECHNIQUES FOR INTRAVASCULAR FOREIGN BODY RETRIEVAL. CARDIOVASCULAR INTERVENTIONAL RADIOLOGY, 36, 888-897. PLEASE NOTE THAT THE EVENT DATE ((B)(6) 2013) WAS PROVIDED INCORRECTLY IN ORDER TO MEET ELECTRONIC MEDWATCH ACCEPTANCE REQUIREMENTS. THE EXACT DATE OF PUBLICATION IS UNKNOWN. THIS IS THE INITIAL AND FINAL REPORT FOR THIS COMPLAINT. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY WOODHOUSE ET AL TECHNIQUES FOR INTRAVASCULAR FOREIGN BODY RETRIEVAL CARDIOVASCULAR INTERVENTIONAL RADIOLOGY 36 (2013) 888-897; A 16-YEAR-OLD GIRL HAD AN OPTEASE TEMPORARY FILTER POSITIONED AT ANOTHER INSTITUTION BUT ATTENDED WITH US FOR ITS REMOVAL. VENOGRAPHY REVEALED EXOLUMINAL POSITIONING OF SOME OF THE DEVICE STRUTS. EFFORTS TO COLLAPSE THE DEVICE CAUSED THE PATIENT PAIN. FURTHER EFFORTS AT ENDOVASCULAR DEVICE EXTRACTION WERE NOT ATTEMPTED. SUBSEQUENT CT (AXIAL AND CORONAL REFORMATS) REVEALED EXTENSIVE NEO-INTIMAL HYPERPLASIA. MULTIDISCIPLINARY TEAM DISCUSSION RESULTED IN A DECISION TO ADVISE AN OPEN SURGICAL RETRIEVAL, PRIMARILY AS A RESULT OF THE YOUNG AGE OF THE PATIENT, MAKING LEAVING IT IN SITU A SUBOPTIMAL LONG-TERM OPTION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. AS STATED IN THE INSTRUCTIONS FOR USE THE OPTEASE RETRIEVABLE FILTER CAN BE RETRIEVED UP TO AND INCLUDING 12 DAYS AFTER PLACEMENT. THE OPTEASE RETRIEVABLE FILTER IS CONSIDERED A PERMANENT IMPLANT IF IT IS NOT RETRIEVED WITHIN THE SPECIFIED TIME PERIOD. VARIOUS COMPLICATIONS HAVE BEEN REPORTED WITH USE OF RETRIEVABLE IVC FILTERS. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL IMPOSSIBLE. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. THE RETRIEVAL DIFFICULTY EXPERIENCED BY THE COSTUMER WAS MOST LIKELY RELATED TO THE LENGTH OF TIME THE FILTER WAS DEPLOYED IN THE PATIENT. INTIMAL OVERGROWTH RESULTING IN AN INTIMAL TEAR DURING ATTEMPTED FILTER REMOVAL IS A KNOWN POTENTIAL COMPLICATION AND LISTED IN THE IFU AS SUCH. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY WOODHOUSE ET AL TECHNIQUES FOR INTRAVASCULAR FOREIGN BODY RETRIEVAL CARDIOVASCULAR INTERVENTIONAL RADIOLOGY 36 (2013) 888-897; A 16-YEAR-OLD GIRL HAD AN OPTEASE TEMPORARY FILTER POSITIONED AT ANOTHER INSTITUTION BUT ATTENDED WITH US FOR ITS REMOVAL. VENOGRAPHY REVEALED EXOLUMINAL POSITIONING OF SOME OF THE DEVICE STRUTS. EFFORTS TO COLLAPSE THE DEVICE CAUSED THE PATIENT PAIN. FURTHER EFFORTS AT ENDOVASCULAR DEVICE EXTRACTION WERE NOT ATTEMPTED. SUBSEQUENT CT (AXIAL AND CORONAL REFORMATS) REVEALED EXTENSIVE NEOINTIMAL HYPERPLASIA. MULTIDISCIPLINARY TEAM DISCUSSION RESULTED IN A DECISION TO ADVISE AN OPEN SURGICAL RETRIEVAL, PRIMARILY AS A RESULT OF THE YOUNG AGE OF THE PATIENT, MAKING LEAVING IT IN SITU A SUBOPTIMAL LONG-TERM OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569038 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening| R| S