BEUDAMED
    FDA Adverse Event Injury Summary report: N

    466FXXXX

    MDR report key: 6796370 · Received August 15, 2017

    Report

    Report Number
    1016427-2017-00551
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    June 9, 2017
    Report Date
    August 15, 2017
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A LITERATURE SEARCH, AN ARTICLE WAS FOUND AS NOTED IN THE PUBLICATION BY DU ET AL: BIDIRECTIONAL PULL-BACK TECHNIQUE FOR RETRIEVAL OF STRUT-EMBEDDED CYLINDER-SHAPED FILTERS IN INFERIOR VENA CAVA, MED SCI MONIT (2017 JUN 09) 23: 2796-2804. THE ARTICLE REFERENCED THE OPTEASE INFERIOR VENA CAVA (IVC) FILTERS. ONE PATIENT REQUIRED A BIDIRECTIONAL PULL-BACK TECHNIQUE PERFORMED FOR FILTER REMOVAL SINCE THE FILTER STRUTS WERE ADHERENT TO THE INFERIOR VENA CAVA (IVC) AFTER SIXTY-SEVEN (67) DAYS INDWELL TIME WITH THE OPTEASE ARM OF THE STUDY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE OPTEASE VENA CAVA FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. THE INSTRUCTIONS FOR USE (IFU) OF THE OPTEASE RETRIEVAL CATHETER IDENTIFIES FILTER RETRIEVAL DIFFICULTY AS A POTENTIAL RISK ASSOCIATED WITH LOG-TERM FILTER IMPLANTATION. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED UP TO 23 DAYS POST IMPLANTATION. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S IFU MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL DIFFICULT. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY. THE LITERATURE ARTICLE IS ATTACHED. THIS IS ONE OF ELEVEN COMPLAINTS FROM THE SAME LITERATURE ARTICLE. THE COMPLAINT NUMBERS ARE: (B)(4). PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    DURING A LITERATURE SEARCH, AN ARTICLE WAS FOUND AS NOTED IN THE PUBLICATION BY DU ET AL: BIDIRECTIONAL PULL-BACK TECHNIQUE FOR RETRIEVAL OF STRUT-EMBEDDED CYLINDER-SHAPED FILTERS IN INFERIOR VENA CAVA, MED SCI MONIT (2017 JUN 09) 23: 2796-2804. THE ARTICLE REFERENCED THE OPTEASE INFERIOR VENA CAVA (IVC) FILTERS. CASE #6 WAS A (B)(6) YEAR-OLD MALE REQUIRED A BIDIRECTIONAL PULL-BACK TECHNIQUE PERFORMED FOR FILTER REMOVAL SINCE THE FILTER STRUTS WERE ADHERENT TO THE INFERIOR VENA CAVA (IVC) AFTER SIXTY-SEVEN (67) DAYS INDWELL TIME WITH THE OPTEASE ARM OF THE STUDY. THE POTENTIAL RISK FACTOR FOR DEEP VEIN THROMBOSIS WAS SPONTANEOUS. THE RECOMMENDED IN-DWELL TIME OF THE OPTEASE FILTER IS TWELVE (12) DAYS, WHICH PROMPTS CLINICIANS TO RETRIEVE THE FILTER WITHIN THE RETRIEVAL TIME WINDOW. WE REVIEWED MEDICAL RECORDS OF ALL PATIENTS WHO RECEIVED FILTER RETRIEVAL IN OUR CENTER FOR TWO (2) YEARS FROM (B)(6) 2014 TO (B)(6) 2016. THE LOCAL INSTITUTIONAL REVIEW BOARD APPROVED THIS RETROSPECTIVE REVIEW. CRITERIA FOR INCLUSION WERE PATIENTS WHO RECEIVED FILTER IMPLANTATION EXCEEDING ROUTINE RETRIEVAL WINDOW OF TWELVE (12) DAYS AND RADIOLOGICALLY DIAGNOSED WITH STRUT-EMBEDDED FILTER, AND WHO FINALLY UNDERWENT BIDIRECTIONAL PULL-BACK TECHNIQUE AFTER FAILED STANDARD RETRIEVAL. A STRUT-EMBEDDED FILTER WAS DEFINED AS BEING REFRACTORY TO STANDARD SNARE TECHNIQUES AND NOMINAL TRACTION RECOMMENDED BY THE MANUFACTURER. RESULTS: TECHNICAL SUCCESS OF FILTER RETRIEVAL WAS ACHIEVED IN 100%, WITH MEAN IMPLANTATION OF 46.6 DAYS (RANGE, 27-66 DAYS). IMMEDIATE POST-PROCEDURE VENOGRAPHY SHOWED NO PROCEDURE-RELATED COMPLICATIONS. THIRTEEN PATIENTS DISCONTINUED PREVIOUSLY PRESCRIBED LIFELONG ANTICOAGULATION. THERE WERE NO LONG-TERM COMPLICATIONS DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573807 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R