BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 14079739 · Received April 11, 2022

    Report

    Report Number
    3002808486-2022-00256
    Event Type
    Injury
    Date Received
    April 11, 2022
    Report Date
    July 21, 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

    INITIAL REPORTER 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.

    Additional Manufacturer Narrative · 0

    G4 (510K): K211874. 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 PERFORATION, PAIN, DISCOMFORT, AND PHYSICAL LIMITATIONS. 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 PAIN, DISCOMFORT , AND PHYSICAL LIMITATIONS ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. (B)(4) IN LOT. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED AGAINST THE LOT. 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 REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THE FOLLOWING FIELDS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED: B2, B5, B6, ANNEX E, ANNEX G, ANNEX B, ANNEX C, ANNEX D, AND H6. INVESTIGATION: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: ORGAN PERFORATION. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE ADDITIONAL INFORMATION REGARDING ORGAN PERFORATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION RESULTS FOR VENA CAVA PERFORATION. 20 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

    IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2010, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED THE GUNTHER TULIP FILTER DUE TO SURGERIES AFTER MOTORCYCLE ACCIDENT. PATIENT IS ALLEGING VENA CAVA PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING "PAIN AND DISCOMFORT", AND "I CAN NO LONGER WORKOUT IN THE GYM OR DO ANY CARDIO EXERCISES".

    Description of Event or Problem · 0

    26JUL2019, PER A REPORT FROM COMPUTED TOMOGRAPHY 2; COOK GUNTHER TULIP FILTER WITH: 5 MM MESENTERIC PERFORATION. NO TILTING, FRACTURE, STENOSIS, OR MIGRATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465890 GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52917 E2537081 10827002529172

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening