BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 8347415 · Received February 18, 2019

    Report

    Report Number
    1820334-2019-00474
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Report Date
    May 2, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: INVESTIGATION: 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 "TULIP: DIFFICULTY IN BREATHING, VC PERFORATION, CHEST PAIN, BLOOD CLOTS, EMOTIONAL DISTRESS, THROMBUS-UPDATED SFC." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. IVC FILTER THROMBUS, OR CLOT IN IVC FILTER, IS AN OUTCOME WHERE THE FILTER HAS EITHER ENTRAPPED A CLOT THAT HAS EMBOLIZED FROM AN UPSTREAM SOURCE, SUCH AS A DEEP VEIN THROMBUS, OR WHERE A CLOT HAS FORMED ON OR WITHIN THE FILTER. FILTER THROMBUS CAN EITHER RESOLVE THROUGH THE PROCESS OF THROMBOLYSIS, REMAIN STATIONARY WITHOUT SUBSEQUENT SEQUELAE, OR ALTERNATIVELY PROVIDE A NIDUS FOR ADDITIONAL CLOT FORMATION. THE PRESENCE OF A FILTER THROMBUS COULD PRECLUDE THE REMOVAL OF THE FILTER DURING A RETRIEVAL PROCESS DUE TO POTENTIAL DISLODGEMENT OF THE THROMBUS WHICH COULD CAUSE A DOWNSTREAM OCCLUSIVE EVENT, E.G. PULMONARY EMBOLISM. IVC FILTER THROMBUS IS DOCUMENTED BY ULTRASOUND (US), CT, MR IMAGING OR VENOGRAPHY. UNKNOWN IF THE REPORTED DIFFICULTY IN BREATHING, CHEST PAIN, BLOOD CLOTS AND EMOTIONAL DISTRESS ARE DIRECTLY RELATED TO THE FILTER. NO RELEVANT NOTES FOUND ON WORK ORDER OR DEVICE LOT. NO OTHER COMPLAINTS ON LOT. PRODUCT 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

    NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER MANUFACTURER REPORT REFERENCE # 3002808486-2018-01519. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS INITIAL REPORT, COOK INC. INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER MANUFACTURER REPORT REFERENCE# (MANUFACTURER REFERENCE NUMBER). PMA/510(K) #: K032426. (B)(4). 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 WAS REPORTED THE PATIENT ALLEGEDLY RECEIVED AN GUNTHER TULIP FEMORAL VENA CAVA FILTER IMPLANT ON (B)(6) 2013 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO BLOOD CLOTS. THE PATIENT IS ALLEGING VENA CAVA PERFORATION WHICH RESULTED IN FILTER REMOVAL. IT WAS ALSO REPORTED THE PATIENT FURTHER ALLEGES TO EXPERIENCE CHEST PAIN, BLOOD CLOTS AND TROUBLE BREATHING MAKING IT MORE DIFFICULT TO GET AROUND. THE FILTER SUCCESSFULLY EXPLANTED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141398 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33016 3845312 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening