BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 14024321 · Received April 6, 2022

    Report

    Report Number
    3002808486-2022-00237
    Event Type
    Injury
    Date Received
    April 6, 2022
    Report Date
    April 6, 2022
    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

    THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED BY COOK INC. UNDER MANUFACTURER REPORT REFERENCE 1820334-2021-00299. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY WILLIAM COOK EUROPE WITH THE SUBMISSION OF THIS INITIAL REPORT, WILLIAM COOK EUROPE INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER THE MANUFACTURER REPORT REFERENCE # OF THIS INITIAL MEDWATCH REPORT. 510(K) - K211874. INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA (VC) PERFORATION, TILT, 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: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. 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 FEAR IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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 BECOME AVAILABLE.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO ACUTE PULMONARY EMBOLISM. PATIENT IS ALLEGING VENA CAVA PERFORATION AND TILT. THE PATIENT FURTHER ALLEGES FEAR. CT REPORT:" A TENT-SHAPED INTERIOR VENA CAVA FILTER IS IN PLACE WITH THE TOP LOCATED AT THE LEVEL OF THE MID CONFLUENCE OF THE RIGHT RENAL VEIN (LOWEST VEIN). THE HEAR THE FILTER ABUTS THE ANTERIOR WALL WITH NO EMBEDMENT. THE FILTER AXIS IS PARALLEL TO THE LONG AXIS OF THE IVC AND CORONAL PLANE, AND IS ANGLED ANTERIORLY BY 11 DEGREES IN THE SAGITTAL PLANE. THERE ARE FOUR DISTAL SUPRASPINATUS. ONE STRUT IS PERFORATION LATERAL TO THE LEFT X4 MM IN THE AXIAL PLANE ABUTTING THE WALL OF THE ABDOMINAL AORTA EXTERNALLY WITH NO BENDING OR PENETRATION. ANTERIOR, POSTERIOR AND RIGHT LATERAL STRUT ARE TENTING THE WALL OF THE IVC (3MM OR LESS IN THE AXIAL PLANE). THE INFERIOR VENA CAVA HAS CALIBER WITHIN NORMAL LIMITS BELOW AND ABOVE THE LEVEL OF THE IVC FILER. " ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT IS NOW EXPIRED. DETAILS SURROUNDING THE PATIENT'S EXPIRATION ARE UNKNOWN AT THIS TIME, AND THERE ARE NO REPORTED ALLEGATIONS OF "WRONGFUL DEATH." ORIGINAL: IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP MREYE ON (B)(6) 2013, 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
    1440654 GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52917 E3141911 10827002529172

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown Life Threatening