BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE RETR FILTER 55 FEMORAL

    MDR report key: 7293404 · Received February 23, 2018

    Report

    Report Number
    9616099-2018-01931
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    January 26, 2018
    Report Date
    March 22, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A RETRIEVAL OF AN OPTEASE FILTER, THE SNARE CAUGHT THE BARB AND REMOVAL WAS UNSUCCESSFUL. THE RETRIEVAL HOOK IS OUTSIDE THE VEIN. 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 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. THE IMPLANTATION DATE OF THE FILTER AND THE ATTEMPTED RETRIEVAL DATE IS UNKNOWN AT THIS TIME. 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, REMODELING/RESTRUCTURING OF THE VESSEL WALL FOLLOWING DEVICE IMPLANTATION, IS THE BODY¿S NATURAL RESPONSE AND HAS BEEN SHOWN TO OCCUR IN AS SHORT A PERIOD AS 12 DAYS. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S IFU MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. PERFORATION OF THE VENA CAVA WAS REPORTED BUT COULD NOT BE CONFIRMED WITHOUT PROCEDURAL/FOLLOW UP FILMS FOR REVIEW. THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY,(B)(4). THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A RETRIEVAL OF AN OPTESE FILTER, THE SNARE CAUGHT THE BARB AND REMOVAL WAS UNSUCCESSFUL. THE RETRIEVAL HOOK IS OUTSIDE THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136306 OPTEASE RETR FILTER 55 FEMORAL THROMBECTOMY SYSTEMS DTK CORDIS CASHEL N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R