BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 2081386 · Received May 9, 2011

    Report

    Report Number
    9616099-2011-00306
    Event Type
    Injury
    Date Received
    May 9, 2011
    Report Date
    April 13, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE FILTER WAS IMPLANTED IN 2010. THE ACTUAL IMPLANT DATE AND EVENT DATE FOR THIS CASE IS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED STATES THAT THE PATIENT HAD AN OPTEASE FILTER PLACED IN HIS "STOMACH" DUE TO A CAR ACCIDENT THAT RESULTED IN A BROKEN FOOT AND A BLOOD CLOT IN THE LEG. ON AN UNKNOWN DATE THE PATIENT HAD SURGERY PERFORMED TO REMOVE THE FILTER THROUGH THE GROIN. HOWEVER, THE FILTER WAS "STUCK" AND WAS UNABLE TO BE REMOVED. A SECOND SURGERY WAS SCHEDULED ON AN UNKNOWN DATE IN AN ATTEMPT TO REMOVE THE FILTER THROUGH THE SHOULDER WHICH WAS ALSO UNSUCCESSFUL. AN ADDITIONAL ATTEMPT WILL BE PERFORMED TO HAVE THE FILTER REMOVED THROUGH THE CHEST. IT IS UNKNOWN IF THE TIME FRAME BETWEEN FILTER INSERTION AND THE ATTEMPTS TO REMOVE THE TEMPORARY FILTER WERE WITHIN THE RECOMMENDED IMPLANT TIME ALLOWED AS PER THE IFU. THERE IS NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT. 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 15120109 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IF THE FILTER HAD BEEN IMPLANTED FOR A LONGER PERIOD OF TIME THAN RECOMMENDED PER THE IFU IT MAY HAVE ENDOTHELIALIZED WHICH COULD ACCOUNT FOR THE INABILITY TO REMOVE IT VIA NORMAL TECHNIQUE. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDENDUM: ADDITIONAL INFORMATION RECEIVED BY MEDICAL AFFAIRS ON (B)(4) 2014, THE PATIENT REPORTED THAT HE HAD A J&J FILTER PLACED IN AN UNKNOWN LOCATION ON (B)(6) 2010 FOR UNKNOWN REASONS. THE PATIENT STATED THE FACILITY THAT PLACED THE VCF SAID THEY PUT A TRAPEASE VCF. THE PATIENT STATES HE HAS AN OPTEASE VCF. PER THE PATIENT, ¿THEY TRIED TO RECEDE THIS THING 3 TIMES ALREADY. HE NOTED THAT "THE FIRST TIME I DIED ON THE TABLE, I HAD A HEART ATTACK THE SECOND TIME AND I' AM WORKING ON A THIRD TIME." CALL WAS ABRUPTLY DISCONNECTED WHILE ON HOLD. NO FURTHER INFORMATION WAS OBTAINED. AN ATTEMPT WAS MADE TO GATHER FURTHER CLARIFICATION/INFORMATION FROM THE PATIENT, THE PATIENT REFUSED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE CC HAS BEEN UPDATED TO REFLECT ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT. ¿THEY TRIED TO RECEDE THIS THING 3 TIMES ALREADY. HE NOTED THAT "THE FIRST TIME I DIED ON THE TABLE, I HAD A HEART ATTACK THE SECOND TIME AND I' AM WORKING ON A THIRD TIME". CALL WAS ABRUPTLY DISCONNECTED WHILE ON HOLD. NO FURTHER INFORMATION WAS OBTAINED. INFORMATION RECEIVED STATES THAT THE PATIENT HAD AN OPTEASE FILTER PLACED IN HIS ¿STOMACH¿ (B)(6) 2010 DUE TO A CAR ACCIDENT THAT RESULTED IN A BROKEN FOOT AND A BLOOD CLOT IN THE LEG. ON AN UNKNOWN AN ATTEMPT WAS MADE TO REMOVE THE FILTER THROUGH THE GROIN. HOWEVER, THE FILTER WAS ¿STUCK¿ AND WAS UNABLE TO BE REMOVED. A SECOND SURGERY WAS SCHEDULED ON AN UNKNOWN DATE IN AN ATTEMPT TO REMOVE THE FILTER THROUGH THE SHOULDER WHICH WAS ALSO UNSUCCESSFUL. AN ADDITIONAL ATTEMPT WILL BE PERFORMED TO HAVE THE FILTER REMOVED THROUGH THE CHEST. IT IS UNKNOWN IF THE TIME FRAME BETWEEN FILTER INSERTION AND THE ATTEMPTS TO REMOVE THE TEMPORARY FILTER WERE WITHIN THE RECOMMENDED IMPLANT TIME ALLOWED AS PER THE IFU. THERE IS NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT. REVIEW OF LOT 15120109 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IF THE FILTER HAD BEEN IMPLANTED FOR A LONGER PERIOD OF TIME THAN RECOMMENDED PER THE IFU IT MAY HAVE ENDOTHELIALIZED WHICH COULD ACCOUNT FOR THE INABILITY TO REMOVE IT VIA NORMAL TECHNIQUE. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INVASIVE PROCEDURE IN WHICH MEDICAL DEVICES/PRODUCTS ARE INSERTED INTO THE PATIENTS VASCULATURE AND MANIPULATED TO VARYING DEGREES AND IS LISTED IN THE IFU AS SUCH. MYOCARDIAL INFARCTION (MI) OR ACUTE MYOCARDIAL INFARCTION (AMI), COMMONLY KNOWN AS A HEART ATTACK IS THE INTERRUPTION OF BLOOD SUPPLY TO PART OF THE HEART, CAUSING SOME HEART CELLS TO DIE. THIS IS MOST COMMONLY DUE TO OCCLUSION (BLOCKAGE) OF A CORONARY ARTERY FOLLOWING THE RUPTURE OF A VULNERABLE ATHEROSCLEROTIC PLAQUE, WHICH IS AN UNSTABLE COLLECTION OF LIPIDS (FATTY ACIDS) AND WHITE BLOOD CELLS (ESPECIALLY MACROPHAGES) IN THE WALL OF AN ARTERY. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THE INHERENT RISK OF THE PROCEDURE COMBINED WITH POSSIBLE PROCEDURAL FACTORS [LONG IMPLANTATION TIME] MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT HAD AN OPTEASE FILTER PLACED IN HIS "STOMACH" DUE TO A CAR ACCIDENT THAT RESULTED IN A BROKEN FOOT AND A BLOOD CLOT IN THE LEG. ON AN UNKNOWN DATE THE PATIENT HAD SURGERY PERFORMED TO REMOVE THE FILTER THROUGH THE GROIN AND DURING THE SURGERY THE FILTER WAS "STUCK" AND IT COULD NOT BE REMOVED. A SECOND SURGERY WAS SCHEDULED ON AN UNKNOWN DATE IN AN ATTEMPT TO REMOVE THE FILTER THROUGH THE SHOULDER AND THE FILTER CONTINUED TO BE "STUCK" AND COULD NOT BE REMOVED. AS TREATMENT A SURGERY WILL BE PERFORMED TO HAVE THE FILTER REMOVED THROUGH THE CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA 15120109

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention