BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 11866009 · Received May 21, 2021

    Report

    Report Number
    3002808486-2021-01252
    Event Type
    Injury
    Date Received
    May 21, 2021
    Report Date
    July 11, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002529172
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4: K211874. INVESTIGATION: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: PERFORATION, UNABLE TO REMOVE, TILT, SOB, CHEST/LEG/ABDOMINAL PAIN, NUMBNESS, IMPAIRED COGNITIVE FUNCTION, VISION IMPAIRMENT/LOSS, INTERNAL DISCOMFORT. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. PHYSICIAN PRACTICE GUIDELINES AND PUBLISHED GUIDANCE FROM REGULATORY AGENCIES RECOMMEND THAT PATIENTS WITH INDWELLING FILTERS UNDERGO ROUTINE FOLLOW-UP. THE RISKS/BENEFITS OF FILTER RETRIEVAL SHOULD BE CONSIDERED FOR EACH PATIENT DURING FOLLOW-UP. ONCE PROTECTION FROM PE IS NO LONGER NECESSARY, FILTER RETRIEVAL SHOULD BE CONSIDERED. FILTER RETRIEVAL SHOULD BE ATTEMPTED WHEN FEASIBLE AND CLINICALLY INDICATED. FILTER RETRIEVAL IS A PATIENT-SPECIFIC, CLINICALLY COMPLEX DECISION; THE DECISION TO REMOVE A FILTER SHOULD BE BASED ON EACH PATIENT¿S INDIVIDUAL RISK/BENEFIT PROFILE (E.G., A PATIENT¿S CONTINUED NEED FOR PROTECTION FROM PE COMPARED TO THEIR EXPERIENCE WITH AND (OR) ONGOING RISK OF EXPERIENCING FILTER-RELATED COMPLICATIONS THE FILTER IS DESIGNED TO BE RETRIEVED WITH THE GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. IT MAY ALSO BE RETRIEVED WITH THE CLOVERSNARE® VASCULAR RETRIEVER. COOK HAS NOT PERFORMED TESTING TO EVALUATE THE SAFETY OR EFFECTIVENESS OF FILTER RETRIEVAL USING OTHER RETRIEVAL SYSTEMS OR TECHNIQUES. THE PUBLISHED CLINICAL LITERATURE INCLUDES DESCRIPTIONS OF ALTERNATIVE TECHNIQUES FOR FILTER RETRIEVAL; USE OF THESE TECHNIQUES VARIES ACCORDING TO PHYSICIAN EXPERIENCE, PATIENT ANATOMY, AND FILTER POSITION. THE SAFETY OR EFFECTIVENESS OF THESE ALTERNATIVE RETRIEVAL TECHNIQUES HAS NOT BEEN ESTABLISHED. SPECIFIC FOR ¿EMBEDDED¿ A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: UNACCEPTABLE FILTER TILT. UNKNOWN IF THE REPORTED SHORTNESS OF BREATH (SOB), CHEST/LEG/ABDOMINAL PAIN, NUMBNESS, IMPAIRED COGNITIVE FUNCTION, VISION IMPAIRMENT/LOSS, AND INTERNAL DISCOMFORT ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. (B)(4) DEVICES IN LOT. NO RELEVANT NOTES ON WORK ORDER. THE 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES 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.

    Description of Event or Problem · 0

    THE PATIENT ALLEGEDLY RECEIVED AN IMPLANT (B)(6) 2014 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO VEIN THROMBOSIS/PULMONARY EMBOLISM (PE). THE PATIENT ALLEGES TILT, UNABLE TO REMOVE, AND PERFORATION. THE PATIENT FURTHER ALLEGES SHORTNESS OF BREATH, CHEST PAIN, LEG PAIN, NUMBNESS IN EXTREMITIES, IMPAIRED COGNITIVE FUNCTION, VISION IMPAIRMENT/LOSS, ABDOMINAL PAIN, AND INTERNAL DISCOMFORT. (B)(6) 2015, PER A REPORT FROM RETRIEVAL REPORT (ATTEMPTED); ¿THE INFERIOR VENA CAVA ANGIOGRAM HAS A NORMAL APPEARANCE. THERE IS NO EVIDENCE FOR THROMBUS IN THE INFERIOR VENA CAVA OF FILTER. THERE IS VARIANT ANATOMY OF THE INFERIOR VENA CAVA. THE IVC FILTER IS IN PROPER POSITION IN THE INFRARENAL INFERIOR VENA CAVA. THE IVC FILTER IS IN PROPER POSITION IN THE INFRARENAL INFERIOR VENA CAVA. ATTEMPTS TO REMOVE THE FILTER THROUGH THE SHEATH WERE UNSUCCESSFUL, LIKELY DUE TO SCAR TISSUE ADHERENT TO THE FILTER.¿

    Additional Manufacturer Narrative · 1

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION AND/OR NO DEVICE FAILURE PROVIDED TO DATE. CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN, HOWEVER, THE ALLEGED 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2014, AND 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
    761552 GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52917 E3211890 10827002529172

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening