BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6130120 · Received November 28, 2016

    Report

    Report Number
    1820334-2016-01376
    Event Type
    Injury
    Date Received
    November 28, 2016
    Report Date
    August 24, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION. NO INFORMATION REGARDING THE EVENT WAS PROVIDED. THE DEVICE WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. NO CONCLUSION CAN BE DRAWN BASED ON THE INCOMPLETE INFORMATION PROVIDED ON ALLEGED INJURIES. THERE IS NOT EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE RE-OPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. 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 ¿ANXIETY". 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.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE ¿PATIENT RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2008 AT (B)(6)MEDICAL CENTER IN (B)(6)." IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 04/28/2017 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED THE FILTER IMPLANT VIA THE RIGHT COMMON FEMORAL VEIN ON (B)(6) 2008 DUE TO PE DESPITE ANTICOAGULATION. PER RECORDS SUBMITTED BY PLAINTIFF, THERE HAS BEEN NO RETRIEVAL ATTEMPT. THE PLAINTIFF ALLEGES ANXIETY REGARDING POSSIBILITY OF FILTER MIGRATION, DESPITE NO EVIDENCE OF FILTER MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781611 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O