BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6345361 · Received February 21, 2017

    Report

    Report Number
    1820334-2017-00278
    Event Type
    Injury
    Date Received
    February 21, 2017
    Report Date
    May 18, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER EVALUATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    (B)(6). DURING THE COURSE OF INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY AND SPECIFICATIONS WAS CONDUCTED. THE REPORTED DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE INVESTIGATION IS BASED REPORTED EVENT WHICH STEMS FROM A LITERATURE ARTICLE AND IMAGE REVIEWS. A TULIP FILTER WAS SUCCESSFULLY RETRIEVED 45 DAYS AFTER PLACEMENT. IT WAS REPORTED THAT VENOGRAM AT TIME OF RETRIEVAL DEMONSTRATED NO SIGNIFICANT TILT AND NO VISIBLE IVC FILTER THROMBUS, BUT STILL PHYSICIAN PERFORMED VARIOUS MANEUVERS TO SNARE THE FILTER AND AFTERWARDS TO COLLAPSE IT; A PIGTAIL CATHETER WAS SPUN AROUND ADJACENT TO THE FILTER HOOK TO DISLODGE ANY HYPOTHESIZED THROMBUS ATTACHED TO THE FILTER HOOK AND A METALLIC BLADED-TIP SHEATH WAS ADVANCED OVER THE SNARE DEVICE THROUGH THE ADHERENT THROMBUS ALLOWING THE FILTER TO COMPLETELY COLLAPSE IN THE RETRIEVAL SHEATH. UTILIZATION OF ADVANCED TECHNIQUES FOR DIFFICULT FILTER RETRIEVALS HAS BEEN EXTENSIVELY DESCRIBED IN THE LITERATURE, BUT IS OFTEN ASSOCIATED WITH DIFFICULTIES IN CAPTURING AND/OR COLLAPSING THE FILTER INTO THE SHEATH. THROMBUS WITHIN THE FILTER MAY BE THE RESULT OF FILTER PERFORMING ITS TASK BY PREVENTING DVT FROM MIGRATING FROM LOWER EXTREMITIES TO PULMONARY ARTERIES, OR THE FILTER MAY HAVE ACTED AS A NIDUS FOR IN SITU THROMBUS FORMATION. HOWEVER, DIFFERENTIATING WHICH OF THESE POTENTIAL CAUSES RESULTED IN THE FILTER THROMBUS IN THIS CASE IS IMPOSSIBLE. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. 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.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: ARTICLE: COMPLEX INFERIOR VENA CAVA FILTER REMOVAL WITH A METALLIC BLADED-TIP MECHANICAL SHEATH.. WADHWANI A, BANDALI M, FARRELL J, KURIACHAN V, HERGET E. J VASC INTERV RADIOL. 2016 NOV;27(11):1726-1727. THE ABOVE REFERENCED JOURNAL ARTICLE ALLEGES: A GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET ((B)(4)) WAS USED; HOWEVER, THE SNARE COULD NOT ENGAGE THE FILTER HOOK. AFTER ORTHOGONAL VENOGRAMS WERE OBTAINED TO CONFIRM NONTILTING OF THE FILTER, THE SNARING DIFFICULTY WAS PRESUMED TO BE SECONDARY TO OCCULT ADHERENT THROMBUS AT THE FILTER HOOK. A 5-F PIGTAIL CATHETER WAS SPUN AROUND THE FILTER TIP, FOLLOWING WHICH THE FILTER WAS SUCCESSFULLY SNARED. HOWEVER, THE 11-F RETRIEVAL SHEATH COULD NOT BE ADVANCED OVER THE FILTER. ATTEMPTS TO COLLAPSE THE FILTER WITH COAXIAL SHEATH DISSECTION USING 45-CM 16-F AND 20-F SHEATHS IN COMBINATION WITH THE 11-F SHEATH WERE UNSUCCESSFUL. DESPITE SIGNIFICANT APPLIED FORCE, THE 20-F SHEATH WOULD PASS ONLY PARTIALLY OVER THE TOP OF THE FILTER RESULTING IN INCOMPLETE COLLAPSE OF THE FILTER LEGS. DURING THIS PROCESS, IT BECAME EVIDENT THAT THE FILTER LEGS WERE NONADHERENT TO THE CAVAL WALL, AS THE FILTER WAS FREELY MOVED INTO THE SUPRARENAL IVC. VENOGRAPHY PERFORMED THROUGH THE 20-F SHEATH DEMONSTRATED A FILLING DEFECT SURROUNDING THE APEX OF THE PARTIALLY COLLAPSED FILTER CONSISTENT WITH ADHERENT THROMBUS (FIG A).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129137 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention