BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2208520 · Received August 11, 2011

    Report

    Report Number
    9616099-2011-00628
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 16, 2009
    Report Date
    July 14, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT POST VENA CAVA OPTEASE FILTER IMPLANTATION THE PATIENT DEVELOPED THROMBOSIS IN THE DEVICE. THERE ARE NO PATIENT DEMOGRAPHICS AVAILABLE TO DATE. A LITERATURE SEARCH REVEALED THE FOLLOWING JOURNAL ARTICLE: ONAT ET AL. "OPTEASE AND TRAPEASE VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE IN 258 CASES" CARDIOVASC INTERVENT RADIOL (2009) 32:992-997 DOI 10.1007/S00270-009-9591. ABSTRACT: WE AIMED TO EVALUATE THE EFFICACY AND SAFETY OF THE OPTEASE AND TRAPEASE (BOTH FROM CORDIS, (B)(4)) VENA CAVA FILTERS IN THE PREVENTION OF PULMONARY EMBOLISM (PE). BETWEEN (B)(6) 2004 AND (B)(6) 2008, OPTEASE (PERMANENT/RETRIEVABLE; N = 228) OR TRAPEASE (PERMANENT; N = 30) VENA CAVA FILTERS WERE PLACED IN 258 PATIENTS (160 FEMALE AND 98 MALE; MEAN AGE 62 YEARS [RANGE 22 TO 97]). INDICATIONS WERE AS FOLLOWS: PROPHYLAXIS FOR PE (N = 239), CONTRAINDICATION FOR ANTICOAGULATION IN THE PRESENCE OF PE OR DVT (N = 10), AND DEVELOPMENT OF PE OR DVT DESPITE ANTICOAGULATION (N = 9). MEDICAL RECORDS WERE RETROSPECTIVELY REVIEWED FOR INDICATIONS, CLINICAL RESULTS, AND PROCEDURE-RELATED COMPLICATIONS DURING PLACEMENT AND RETRIEVAL. CLINICAL PE DID NOT DEVELOP IN ANY OF THE PATIENTS. HOWEVER, RADIOLOGIC SIGNS OF SEGMENTAL PE WERE SEEN IN 6 OF 66 PATIENTS WITH FOLLOW-UP IMAGING DATA. MIGRATION OR FRACTURE OF THE FILTER OR CAVA PERFORATION WAS NOT SEEN IN ANY OF THE PATIENTS. EXCEPT FOR A SINGLE CASE OF ASYMPTOMATIC TOTAL CAVA THROMBOSIS, NO THROMBOTIC OCCLUSION WAS OBSERVED. ONE HUNDRED FORTY-ONE PATIENTS WERE SCHEDULED TO UNDERGO FILTER REMOVAL; HOWEVER, 17 OF THEM WERE NOT SUITABLE FOR SUCH BASED ON VENOGRAPHY EVALUATION. REMOVAL WAS ATTEMPTED IN 124 PATIENTS AND WAS SUCCESSFUL IN 115 OF THESE (MEAN DURATION OF RETENTION 11 DAYS [RANGE 4 TO 23]). NINE FILTERS COULD NOT BE REMOVED. PERMANENT/RETRIEVABLE VENA CAVA FILTERS ARE SAFE AND EFFECTIVE DEVICES FOR PE PROPHYLAXIS AND FOR THE MANAGEMENT OF VENOUS THROMBOEMBOLISM BY PROVIDING THE OPTION TO BE LEFT IN PLACE. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. THROMBOSIS IN THE DEVICE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF VENA CAVA FILTERS AND IS LISTED IN THE IFU AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. PATIENTS WHO UNDERGO VENA CAVA FILTER IMPLANTATION ARE USUALLY UNABLE TO BE MAINTAINED ON AN ANTICOAGULATION MEDICATION REGIMEN THUS THE NEED FOR MECHANICAL BLOCKADE OF THE POTENTIAL EMBOLI. THESE PATIENTS CONTINUE TO DEVELOP THROMBOSIS IN THEIR VASCULAR SYSTEMS. THE FILTER IS DESIGNED AS A PROPHYLAXIS AGAINST EMBOLISMS TRAVELING TO THE CENTRAL CIRCULATION I.E. THE HEART, LUNGS AND BRAIN. THE OPTEASE FILTER, AS WELL AS OTHER VENA CAVA FILTERS, IS AN OPEN FRAMEWORK OF METAL STRUTS DESIGNED TO PREVENT EMBOLISMS ABOVE A CERTAIN SIZE FROM TRAVELING FROM THE PERIPHERY TO THE CENTRAL VENOUS SYSTEM. UNFORTUNATELY THE BURDEN OF THROMBOEMBOLIC DEBRIS MAY OVERWHELM THE FILTER DEVICE'S DESIGN TO STRAIN THE CIRCULATING BLOOD OF LARGE CLOTS. LARGE SIZE EMBOLI OR LARGE NUMBERS OF MODERATE TO SMALL EMBOLI CAN BECOME CAUGHT IN THE DEVICE AND CREATE THROMBOSIS WITHIN THE FILTER ITSELF. THIS IS A SUCCESS IN THAT THE THROMBUS HAS BEEN PREVENTED FROM FLOWING UPSTREAM; HOWEVER, THIS CREATES A CESSATION OF FLOW FROM THE PERIPHERY CAUSING DISTAL SYMPTOMS. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT AND MEDICATION REGIMEN FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ABSTRACT: WE AIMED TO EVALUATE THE EFFICACY AND SAFETY OF THE OPTEASE AND TRAPEASE (BOTH FROM CORDIS, (B)(4)) VENA CAVA FILTERS IN THE PREVENTION OF PULMONARY EMBOLISM (PE). BETWEEN (B)(6) 2004 AND (B)(6) 2008, OPTEASE (PERMANENT/RETRIEVABLE; N = 228) OR TRAPEASE (PERMANENT; N = 30) VENA CAVA FILTERS WERE PLACED IN 258 PATIENTS (160 FEMALE AND 98 MALE; MEAN AGE 62 YEARS [RANGE 22 TO 97]). INDICATIONS WERE AS FOLLOWS: PROPHYLAXIS FOR PE (N = 239), CONTRAINDICATION FOR ANTICOAGULATION IN THE PRESENCE OF PE OR DVT (N = 10), AND DEVELOPMENT OF PE OR DVT DESPITE ANTICOAGULATION (N = 9). MEDICAL RECORDS WERE RETROSPECTIVELY REVIEWED FOR INDICATIONS, CLINICAL RESULTS, AND PROCEDURE-RELATED COMPLICATIONS DURING PLACEMENT AND RETRIEVAL. CLINICAL PE DID NOT DEVELOP IN ANY OF THE PATIENTS. HOWEVER, RADIOLOGIC SIGNS OF SEGMENTAL PE WERE SEEN IN 6 OF 66 PATIENTS WITH FOLLOW-UP IMAGING DATA. MIGRATION OR FRACTURE OF THE FILTER OR CAVA PERFORATION WAS NOT SEEN IN ANY OF THE PATIENTS. EXCEPT FOR A SINGLE CASE OF ASYMPTOMATIC TOTAL CAVA THROMBOSIS, NO THROMBOTIC OCCLUSION WAS OBSERVED. ONE HUNDRED FORTY-ONE PATIENTS WERE SCHEDULED TO UNDERGO FILTER REMOVAL; HOWEVER, 17 OF THEM WERE NOT SUITABLE FOR SUCH BASED ON VENOGRAPHY EVALUATION. REMOVAL WAS ATTEMPTED IN 124 PATIENTS AND WAS SUCCESSFUL IN 115 OF THESE (MEAN DURATION OF RETENTION 11 DAYS [RANGE 4 TO 23]). NINE FILTERS COULD NOT BE REMOVED. PERMANENT/RETRIEVABLE VENA CAVA FILTERS ARE SAFE AND EFFECTIVE DEVICES FOR PE PROPHYLAXIS AND FOR THE MANAGEMENT OF VENOUS THROMBOEMBOLISM BY PROVIDING THE OPTION TO BE LEFT IN PLACE. CONCLUSION: OPTEASE AND TRAPEASE VENA CAVA FILTERS ARE SAFE AND EFFECTIVE DEVICES FOR PE PROPHYLAXIS AND FOR THE MANAGEMENT OF VTE. THE MOST IMPORTANT LIMITATION OF OPTEASE AS A RETRIEVABLE FILTER IS ITS REQUIREMENT FOR AN EARLY RETRIEVAL. AS SUCCESSFUL RETRIEVAL RATES INCREASE, THE USE OF VENA CAVA FILTERS WILL BECOME MORE COMMON. IT SEEMS POSSIBLE THAT RETRIEVABLE FILTERS MAY ALSO BE USED AS PERMANENT FILTERS WHEN NECESSARY AND THAT THE USE OF PERMANENT FILTERS EVENTUALLY MAY BE COMPLETELY ABANDONED. HOWEVER, FURTHER LONG-TERM AND LARGE-SCALE PROSPECTIVE STUDIES ARE WARRANTED BEFORE A DEFINITE CONCLUSION CAN BE ACHIEVED. OPTEASE AND TRAPEASE VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE IN 258 PATIENTS-JOURNAL ARTICLE. WE HAVE CAPTURED THE PRODUCT ISSUES IN THIS ARTICLE AS: THROMBOSIS IN DEVICE (16): (B)(4). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A LITERATURE SEARCH REVEALED THE FOLLOWING JOURNAL ARTICLE: ONAT ET AL. "OPTEASE AND TRAPEASE VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE IN 258 CASES" CARDIOVASC INTERVENT RADIOL (2009) 32:992-997 DOI 10.1007/S00270-009-9591. THE ARTICLE/REPORT STATED THAT AFTER VENOGRAPHY OF THE VENA CAVA, REMOVAL OF THE DEVICE WAS ABANDONED FOR THE FOLLOWING REASONS: THROMBUS EITHER IN THE FILTER OR THE VENA CAVA, CAVA THROMBOSIS OR THE PRESENCE OF CEMENT FROM VERTEBROPLASTY. A TOTAL OF SIXTEEN (16) EVENTS OF THROMBOSIS IN DEVICE WERE CAPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1