BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

    MDR report key: 23660848 · Received November 26, 2025

    Report

    Report Number
    3002808486-2025-00249
    Event Type
    Injury
    Date Received
    November 26, 2025
    Report Date
    November 26, 2025
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT FOR THE INITIAL REPORT SUBMITTED WITH REFERENCE NUMBER 3002808486-2017-00323 ON 03FEB2017. THE SUBSEQUENT FOLLOW-UP DATES INCLUDE: FOLLOW-UP #1 - SENT ON 02APR2017. FOLLOW-UP #2 - SENT ON 27MAY2017. THIS REPORT IS FOLLOW-UP #3. CORRECTED INFORMATION: A1, B1, B2, D3 (EMAIL), G1 (CONTACT DETAILS & MFG SITE EMAIL), H1 AND H6 (ANNEXES E & F) ADDITIONAL INFORMATION: B5 AND H6 (ANNEX E (E2337-STENOSIS)). INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: DIFFICULT TO REMOVE, HEMATOMA AND NARROWING OF THE IVC, AND PREVIOUSLY INVESTIGATED: IVC PERFORATION, TILT, BLEEDING AND BACK & CHEST PAIN. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE NEW INFORMATION PROVIDED IS: DIFFICULT TO REMOVE, HEMATOMA AND NARROWING OF THE IVC. 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. UNKNOWN IF THE REPORTED HEMATOMA OR "NARROWING OF THE IVC" IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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 FOLLOWING ADDITIONAL INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2014. APPROXIMATELY ONE MONTH LATER, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE ABDOMEN THAT SHOWED THE FILTER TILTED. IT IS NOTED THAT THERE IS A HEMATOMA ADJACENT TO THE IVC. APPROXIMATELY ONE MONTH LATER, THE PATIENT UNDERWENT ANOTHER COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE ABDOMEN, WHICH SHOWED NARROWING OF THE IVC AT THE LEVEL OF THE FILTER. APPROXIMATELY FIVE MONTHS LATER, THE PATIENT UNDERWENT A COMPLEX RETRIEVAL ATTEMPT. THE FILTER WAS TILTED WITH MULTIPLE STRUT PERFORATIONS. THE ATTEMPTED REMOVAL WAS ABORTED AFTER SEVERAL ATTEMPTS INVOLVING A LOOP SNARE, SHEARING TECHNIQUE, AND FORCEPS ALL FAILED. FOLLOWING THE FAILED ATTEMPT TO REMOVE THE FILTER, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") APPROXIMATELY ONE MONTH LATER, WHICH SHOWED MULTIPLE STRUT PERFORATING IVC. DURING A SUBSEQUENT HEMATOLOGY VISIT APPROXIMATELY TWO MONTHS LATER, THE PATIENT'S PRIMARY HEMATOLOGIST RECOMMENDED AGAINST ANOTHER ATTEMPT AT REMOVING THE FILTER AT THE TIME AS THE RISKS OF RETRIEVAL OUTWEIGHED KEEPING THE FILTER IN PLACE. APPROXIMATELY SEVEN MONTHS AND NINE MONTHS AFTER THE VISIT, THE PATIENT UNDERWENT COMPUTERIZED TOMOGRAPHY SCANS ("CT SCANS"), BOTH OF WHICH AGAIN DEMONSTRATED THAT MULTIPLE STRUTS WERE PERFORATING IVC. APPROXIMATELY A MONTH LATER, THE PATIENT REQUIRED A COMPLEX PERCUTANEOUS PROCEDURE TO REMOVE THE IVC FILTER. THIS IS A FOLLOW-UP REPORT FOR THE INITIAL REPORT SUBMITTED WITH REFERENCE NUMBER 3002808486-2017-00323 ON 03FEB2017. THE SUBSEQUENT FOLLOW-UP DATES INCLUDE: FOLLOW-UP #1 - SENT ON 02APR2017 FOLLOW-UP #2 - SENT ON 27MAY2017 THIS REPORT IS FOLLOW-UP #3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865015 DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening