BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 17654786 · Received August 30, 2023

    Report

    Report Number
    3002808486-2023-00229
    Event Type
    Injury
    Date Received
    August 30, 2023
    Report Date
    August 30, 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

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SECTION E3: NON-HEALTHCARE PROFESSIONAL. G4 (510K): K211874. INVESTIGATION: THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA (VC) PERFORATION, FEAR. 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. UNKNOWN IF THE REPORTED FEAR IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. (B)(4) DEVICES IN LOT. ONE OTHER COMPLAINT HAS BEEN REPORTED AGAINST THE LOT FOR A DIFFERENT ISSUE. THE ASSOCIATED WORK ORDER WAS REVIEWED. NO RELATED/RELEVANT NOTES WERE DOCUMENTED. THE DEVICE 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

    IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013 VIA THE RIGHT FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT)/ PULMONARY EMBOLISM (PE). ALLEGATIONS INCLUDE: VENA CAVA PERFORATION. IT IS FURTHER ALLEGED THE PATIENT EXPERIENCED "FEAR THAT THE FILTER MIGHT CAUSE FURTHER DAMAGE AS IT HAS NOT YET BEEN REMOVED. " THE PATIENT REPORTEDLY EXPIRED (B)(6) 2021 AND THERE IS CURRENTLY NO REPORTED ALLEGATION OF WRONGFUL DEATH. PER CT REPORT, "FILTER CONE POSITION: BELOW." "FILTER PENETRATION: YES." "IMPRESSIONS: FILTER STRUT PENETRATION THROUGH THE IVC WALL: POSTERIOR LEFT: 14 MM, CORONAL IMAGE 58. POSTERIOR RIGHT: 9 MM, CORONAL IMAGE 60. ANTERIOR LEFT: 15MM, CORONAL IMAGE 51. ANTERIOR RIGHT: NONE." PER CT REPORT, "AN IVC FILTER IS IN PLACE. THE TIP OF THE FILTER LIES JUST BELOW THE LEVEL OF THE LEFT RENAL VEIN. THE POSTERIOR PRONGS OF THE FILTER APPEAR TO EXTEND BEYOND THE LUMEN OF THE IVC BUT DO NOT ABUT THE SPINE. NO ASSOCIATED HEMORRHAGE OR INFLAMMATORY CHANGE." PER CERTIFICATE OF DEATH, DATED (B)(6) 2021, "CAUSE OF DEATH: DRUG INDUCED CARDIAC ARRHYTHMIA (COCAINE, METHORPHAN, DOXYLAMINE, FENTANYL, ALPRAZOLAM, NORBUPRENORPHINE)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287017 GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3047817 10827002529172

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening