BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 8137445 · Received December 6, 2018

    Report

    Report Number
    1820334-2018-03607
    Event Type
    Injury
    Date Received
    December 6, 2018
    Report Date
    April 9, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5-PMA/510(K) #:K072240. H6-PATIENT CODES: VESSELS, PERFORATION OF (2135)-LISTED IN IFU; ORGAN(S), PERFORATION OF (1987)-NOT LISTED IN IFU;THROMBOSIS (2100)- LISTED IN IFU; VESSEL OR PLAQUE, DEVICE EMBEDDED IN (1204)-NOT LISTED IN IFU. H6-DEVICE CODES: APPROPRIATE TERM/CODE NOT AVAILABLE (3191): SELECTED FOR PERFORATION-LISTED IN IFU; MIGRATION (4003)-NOT LISTED IN IFU. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    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 ¿GUNTHER TULIP FILTER IMPLANTED". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. CATALOG AND LOT# ARE UNKNOWN, BUT THE FILTER TULIP IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2006 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO THE INABILITY TO TAKE ANTICOAGULANTS. THE PATIENT IS ALLEGING MIGRATION, TILT, VENA CAVA PERFORATION, AND ORGAN PERFORATION, DEEP VEIN THROMBOSIS AND EMBEDMENT. (B)(6) 2016, COMPUTED TOMOGRAPHY ABDOMEN PELVIS WITH INTRAVENOUS CONTRAST/WITHOUT ORAL CONTRAST: "FILTER IS TILTED ANTERIORLY WITH ITS CONE LYING ON THE WALL OF THE INFERIOR VENA CAVA POSSIBLY EMBEDDED WITHIN IT. THE LEGS OF THE FILTER PENETRATED THROUGH THE WALL OF THE INFERIOR VENA CAVA INTO THE PERICAVAL/MESENTERIC FAT. ONE OF THE LEGS OF THE FILTER IS IN CONTRAST WITH THE ANTERIOR PERIOSTEUM OF THE LUMBAR VERTEBRA WITH ASSOCIATED CHRONIC REACTIVE CHANGES. THIS MAY INDICATE EMBEDMENT."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL DETAILS PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED. NON-HEALTHCARE PROFESSIONAL. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PLAINTIFF RECEIVED A GUNTHER FILTER ON (B)(6) 2006. IT IS ALLEGED THAT THE PLAINTIFF 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
    976831 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC 1587106

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O