BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTEASE RETRIEVAL FILTER

    MDR report key: 12956681 · Received December 7, 2021

    Report

    Report Number
    9616099-2021-05134
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    July 12, 2021
    Report Date
    April 18, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    UDI-DI
    20705032009413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION: OTHER, SENIOR COUNSEL, LITIGATION. PLEASE NOTE THAT THE EXACT EVENT DATE IS UNKNOWN AND THE EVENT DATE IS THE COMPLAINT AWARENESS DATE. AS REPORTED A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED THROMBOSIS. THE INDICATION FOR THE FILTER IMPLANT, PROCEDURAL DETAILS AND PATIENT MEDICAL HISTORY HAVE NOT BEEN PROVIDED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE STERILE LOT NUMBER HAS NOT BEEN PROVIDED; THEREFORE, NO DEVICE ANALYSIS NOR DEVICE HISTORY RECORD REVIEW COULD 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 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. THROMBOSIS WAS REPORTED. BLOOD CLOTS, CLOTTING AND OCCLUSIVE THROMBOSIS OF THE FILTER AND/OR THE VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND VESSEL CHARACTERISTICS. WITHOUT THE PROCEDURAL FILMS OR POST-PLACEMENT IMAGING AND THE LIMITED INFORMATION PROVIDED, THE REPORT OF THROMBOSIS COULD NOT BE CONFIRMED OR FURTHER CLARIFIED. GIVEN THE LIMITED INFORMATION CURRENTLY AVAILABLE FOR REVIEW, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENTS ARE 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. PLEASE NOTE THAT THIS IS THE INITIAL REPORT FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 0

    AS REPORTED A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED THROMBOSIS. THE PATIENT REPORTED BECOMING AWARE OF FILTER FRACTURE, BLOOD CLOTS, CLOTTING, AND/OR OCCLUSION OF THE INFERIOR VENA CAVA (IVC), APPROXIMATELY NINE YEARS AND ELEVEN MONTHS POST IMPLANT. THE PATIENT ALSO REPORTED ANXIETY RELATED TO THE FILTER. ACCORDING TO THE MEDICAL RECORDS THE PATIENT MEDICAL HISTORY WAS NOTED FOR BACK PAIN, MORBID OBESITY HYPERCOAGULABLE STATE, THROMBOEMBOLIC DISEASE AND DEEP VEIN THROMBOSIS (DVT). THE PATIENT HAD BEEN ON LONG-TERM ANTICOAGULATION AND SUBSEQUENTLY DEVELOPED AN INFECTED HEMATOMA IN THE LEFT LOWER EXTREMITY WITH CELLULITIS AND UNDERWENT A RECENT DEBRIDEMENT. THE FILTER WAS PLACED VIA THE FEMORAL VEIN AND DEPLOYED AT THE L3 VERTEBRAL BODY. THE PATIENT TOLERATED THE PRESSURE WELL WITH NO COMPLICATIONS. THE PRODUCT REMAINS IMPLANT AND THEREFORE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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 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. THROMBOSIS WAS REPORTED. BLOOD CLOTS, CLOTTING AND OCCLUSIVE THROMBOSIS OF THE FILTER AND/OR THE VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND VESSEL CHARACTERISTICS. THE INSTRUCTIONS FOR USE (IFU) STATES THAT FILTER FRACTURE IS A POTENTIAL COMPLICATION OF VENA CAVA FILTERS. ANATOMIC LOCATIONS THAT CREATE CONCENTRATED STRESS POINTS FROM FILTER DEFORMATION (FOR EXAMPLE, DEPLOYMENT AT APEX OF SCOLIOSIS, OVERLAPPING OF EITHER OF THE RENAL OSTIA, OR PLACEMENT ADJACENT TO A VERTEBRAL OSTEOPHYTE) MAY CONTRIBUTE TO FRACTURE OF A PARTICULAR FILTER STRUT. WITHOUT THE PROCEDURAL FILMS OR POST-PLACEMENT IMAGING AND THE LIMITED INFORMATION PROVIDED, THE REPORT EVENTS COULD NOT BE CONFIRMED OR FURTHER CLARIFIED. ANXIETY DOES NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT SPECIFIC ISSUES. GIVEN THE LIMITED INFORMATION CURRENTLY AVAILABLE FOR REVIEW, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENTS ARE 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 · 0

    AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO THROMBOSIS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF BACK PAIN, MORBID OBESITY, HYPERCOAGULABLE STATE, THROMBOEMBOLIC DISEASE AND DEEP VEIN THROMBOSIS (DVT). THE PATIENT HAD BEEN ON LONG-TERM ANTICOAGULATION THERAPY AND SUBSEQUENTLY DEVELOPED AN INFECTED HEMATOMA IN HIS LEFT LOWER EXTREMITY, CELLULITIS AND HAD RECENT DEBRIDEMENT. THE FILTER WAS IMPLANTED VIA THE PATIENT'S FEMORAL VEIN. WITH THE OPTEASE INTRODUCER SHEATH DILATOR SYSTEM IN PLACED AT THE L2 LEVEL A VENOGRAM WAS PERFORMED. THIS WAS SOMEWHAT LIMITED IN ITS OPACITY DUE TO THE PATIENT'S BODY HABITUS. ULTIMATELY THE ANATOMY WAS IDENTIFIED AND THE INTRODUCER SHEATH WAS POSITIONED AT THE MID L3 VERTEBRAL BODY. UNDER FLUOROSCOPIC GUIDANCE THE FILTER WAS DEPLOYED. THE PATIENT REMAINED STABLE THROUGHOUT. HEMOSTASIS WAS ACHIEVED WITH A THROMBIX PAD AND MANUAL PRESSURE. THE PATIENT TOLERATED THE PRESSURE WELL. THERE WERE NO COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED FRACTURED FILTER, BLOOD CLOTS, CLOTTING, AND/OR OCCLUSION OF THE INFERIOR VENA CAVA (IVC). THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY NINE YEARS AND ELEVEN MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT CONTINUES TO EXPERIENCE ANXIETY/WORRY RELATED TO THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853502 PTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CORPORATION 466F220A 15414364 20705032009413

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Life Threatening OPTEASE INTRODUCER SHEATH DILATOR SYSTEM.| UNKNOWN 0.035 GLIDE WIRE.| UNKNOWN 6 FRENCH INTRODUCER SHEATH.| UNKNOWN SHORT 6 FRENCH SHEATH.| UNKNOWN.