BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    466P306X

    MDR report key: 7290744 · Received February 22, 2018

    Report

    Report Number
    1016427-2018-01217
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    November 1, 2017
    Report Date
    February 26, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS AN UNKNOWN TRAPEASE FILTER AND THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS: CHICK, J. F. (2017). RADIOGRAPHIC FINDINGS OF DISTRESSED VENOUS STENTS AND INFERIOR VENA CAVA FILTERS: CLINICAL IMPLICATIONS. AMERICAN JOURNAL OF ROENTGENOLOGY, 209(5), 1150-1157. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS AN UNKNOWN TRAPEASE FILTER AND THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. THE CITATION IS AS FOLLOWS: CHICK, J. F. (2017). RADIOGRAPHIC FINDINGS OF DISTRESSED VENOUS STENTS AND INFERIOR VENA CAVA FILTERS: CLINICAL IMPLICATIONS. AMERICAN JOURNAL OF ROENTGENOLOGY, 209(5), 1150-1157. COMPLAINT CONCLUSION: AS REPORTED IN THE PUBLICATION CHICK ET AL RADIOGRAPHIC FINDINGS OF DISTRESSED VENOUS STENTS AND INFERIOR VENA CAVA FILTERS: CLINICAL IMPLICATIONS; AJR AM J ROENTGENOL. 2017 NOV;209(5):1150-1157; THREE TRAPEASE FILTERS CONTRACTED AFTER IMPLANTATION. THE MEAN TIME TO IDENTIFICATION OF AND TYPE OF IMPLANT DISTRESS WAS 66.2 MONTHS. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD (DHR) REVIEWS COULD NOT BE PERFORMED. THE INFERIOR 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 PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. WITHOUT PROCEDURAL FILMS AND POST FILMS AVAILABLE FOR REVIEW, THE REPORTED INCOMPLETE EXPANSION (CONTRACTURE) COULD NOT BE CONFIRMED AND THE EXACT CAUSE AND TIME OF EVENT COULD NOT BE DETERMINED. UPON DEPLOYMENT, THE FILTER IMPARTS AN OUTWARD RADIAL FORCE ON THE LUMINAL SURFACE OF THE VENA CAVA TO ENSURE PROPER POSITIONING AND STABILITY. AS NOTED IN THE INSTRUCTIONS FOR USE (IFU), THE CONSTRAINED, UNEXPANDED, LENGTH OF THE TRAPEASE FILTER IS 64 MM. DURING RELEASE FROM THE SHEATH INTRODUCER, THE LENGTH OF THE FILTER WILL SHORTEN AS IT EXPANDS. THE ENDS OF THE FILTER WILL SHORTEN EQUALLY AS THEY MOVE TOWARD THE AXIAL CENTER OF THE FILTER. THE PHYSICIAN IS ALSO INSTRUCTED IN THE IFU TO PERFORM A CONTROL CAVOGRAM BEFORE TERMINATING THE PROCEDURE. 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.

    Description of Event or Problem · 1

    AS REPORTED IN THE PUBLICATION CHICK ET AL RADIOGRAPHIC FINDINGS OF DISTRESSED VENOUS STENTS AND INFERIOR VENA CAVA FILTERS: CLINICAL IMPLICATIONS; AJR AM J ROENTGENOL. 2017 NOV;209(5):1150-1157; THREE TRAPEASE FILTERS CONTRACTED AFTER IMPLANTATION. THE MEAN TIME TO IDENTIFICATION OF AND TYPE OF IMPLANT DISTRESS WAS 66.2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132547 466P306X CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS CASHEL 466P306X UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening