BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU

    MDR report key: 1913581 · Received December 3, 2010

    Report

    Report Number
    9610978-2010-00249
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 8, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K023116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS ADMITTED DUE TO A SEVERE DEEP VEIN THROMBOSIS IN THE LOWER LEFT LIMB. AN ULTRASOUND REVEALED THAT THE LEFT COMMON ILIAC VEIN AND THE LEFT EXTERNAL ILIAC VEIN HAD THROMBOSIS. THERE WAS BLOOD FLOW OBSTRUCTION BELOW THE LEFT EXTERNAL ILIAC. THE VENA CAVA WAS A NORMAL SHAPE AND MEASURED 22MM. THE RIGHT FEMORAL ARTERY VEIN WAS USED AS THE PUNCTURE SITE AND THE PHYSICIAN RELEASED AN OPTEASE FILTER ABOVE LUMBAR 2. THEN, THE PHYSICIAN ADVANCED AN ANGIO PULSESPRAY INFUSION CATHETER THROUGH LEFT POPLITEAL VEIN AND ADVANCED THE THROMBOLYSIS CATHETER THROUGH THE HOLE OF THE FILTER TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN WITHDREW THE THROMBOLYSIS CATHETER, THE FILTER AND THE CATHETER MOVED TO THE LEFT COMMON ILIAC VEIN TOGETHER AND THE FILTER BECAME SEVERELY DISTORTED. THE PHYSICIAN CONVERTED TO OPEN SURGERY TO TAKE OUT THE FILTER AND THE THROMBOLYSIS CATHETER FROM THE PATIENT. THE PATIENT IS IN STABLE CONDITION. ONE UNKNOWN NON STERILE CATHETER WAS RETURNED INSIDE A PLASTIC BAG ATTACHED TO AN OPTEASE RETRIEVABLE FILTER 55 CM. A STRUT OF THE FILTER WAS OBSERVED BROKEN AND UPLIFTED. NO BLOOD RESIDUES WERE NOTED ON THE FILTER. THE NON CORDIS CATHETER PRESENTED KINKS. A SCANNING ELECTRON MICROSCOPE WAS PERFORMED ON THE SURFACE OF THE FILTER IN ORDER TO DETERMINE THE POSSIBLE CAUSE OF THE BROKEN STRUT. THE FRACTURE SITES PRESENTED EVIDENCE OF SMEARING IN THE EDGES AND EXTERNAL DAMAGES FOUND NEXT TO THE FAILURE SITES. NO CUTTING OR CHEMICAL ATTACK CHARACTERISTICS WERE NOTED IN THE FRACTURE SURFACES, INSTEAD DUCTILE DIMPLES CAN BE OBSERVED IN THE FRACTURE SURFACE WHICH SUGGESTS PULLING UNTIL FAILURE; HOWEVER THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE EXACT CAUSES OF THE BROKEN STRUT COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15172225 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15172225. MANUFACTURING RECORDS FOR LOT 15172225 WAS REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO NITINOL DEVICES & COMPONENTS (NDC), FOR PART NUMBER: (B)(4) AND FILTER LOT NUMBERS 518971AND 517435; RESULTS INDICATE THAT THE FILTER SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. THE CUSTOMER COMPLAINT REPORTED AS 'FILTER KINKED/BENT STRUT' WAS CONFIRMED SINCE THE FILTER WAS BROKEN, THE CAUSE OF FAILURE WAS NOT CONCLUSIVELY DETERMINED, PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO THE FAILURE, NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW OR THE SEM ANALYSIS SUGGEST THAT THE FAILURE IS RELATED TO MANUFACTURING, THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED DUE TO A SEVERE DEEP VEIN THROMBOSIS IN THE LOWER LEFT LIMB. AN ULTRASOUND REVEALED THAT THE LEFT COMMON ILIAC VEIN AND THE LEFT EXTERNAL ILIAC VEIN HAD THROMBOSIS. THERE WAS BLOOD FLOW OBSTRUCTION BELOW THE LEFT EXTERNAL ILIAC. THE VENA CAVA WAS A NORMAL SHAPE AND MEASURED 22MM. THE RIGHT FEMORAL ARTERY VEIN WAS USED AS THE PUNCTURE SITE, AND THE PHYSICIAN RELEASED AN OPTEASE FILTER ABOVE LUMBAR 2. THEN, THE PHYSICIAN ADVANCED AN ANGIO PULSESPRAY INFUSION CATHETER THROUGH LEFT POPLITEAL VEIN AND ADVANCED THE THROMBOLYSIS CATHETER THROUGH THE HOLE OF THE FILTER TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN WITHDREW THE THROMBOLYSIS CATHETER, THE FILTER AND THE CATHETER WERE MOVED TO LEFT COMMON ILIAC VEIN TOGETHER, THE FILTER WAS SEVERELY DISTORTION. THE PHYSICIAN CONVERTED TO OPEN TO TAKE OUT THE FILTER AND THE THROMBOLYSIS CATHETER FROM THE PATIENT AND CHANGED TO USE ANOTHER FILTER TO COMPLETE THE PROCEDURE. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. 15172225

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention