BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6618472 · Received June 7, 2017

    Report

    Report Number
    1820334-2017-01381
    Event Type
    Injury
    Date Received
    June 7, 2017
    Report Date
    October 23, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K: 510(K) K072240 NOT RESOLVED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    CORRECTION(S): FROM PRODUCT PROBLEM TO ADVERSE EVENT AND PRODUCT PROBLEM. TYPE OF EVENT FROM MALFUNCTION TO SERIOUS INJURY. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING, ¿ARRHYTHMIA, FILTER IN PLACE MORE THAN 90 DAYS AND TOO RISKY TO ATTEMPT RETRIEVAL." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. UNKNOWN IF THE REPORTED ARRHYTHMIA IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

    Additional Manufacturer Narrative · 1

    PATIENT AND DEVICE CODE: NO INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 07/05/2017 AS FOLLOWS: PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2008 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS. PATIENT IS ALLEGING ARRHYTHMIA AND THAT THE FILTER HAS BEEN IN PLACE MORE THAN 90 DAYS AND IT'S TOO RISKY TO ATTEMPT RETRIEVAL. PATIENT ALLEGEDLY RECEIVED A GREENFIELD FILTER IN 1998 PRIOR TO HIP REPLACEMENT.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT [PT] RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2008. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400776 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other