BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 6205019 · Received December 27, 2016

    Report

    Report Number
    1820334-2016-01607
    Event Type
    Injury
    Date Received
    December 27, 2016
    Report Date
    November 30, 2016
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, SPECIFICATIONS, IMAGING, AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THIS INVESTIGATION. INVESTIGATION IS BASED ON EVENT DESCRIPTION AND IMAGE REVIEW BY COOK RESEARCH INC: DUE TO UPPER EXTREMITY DVT A TULIP FILTER WAS PLACED IN SUPERIOR VENA CAVA WITHOUT INCIDENT AND FOURTEEN DAYS LATER IT WAS REMOVED DUE TO DECREASED LEFT UPPER EXTREMITY CLOT. THE RETRIEVAL VENOGRAM DEMONSTRATED NO EVIDENCE TO PERFORATION, BUT POST-PROCEDURE VENOGRAM AND NONCONTRAST CT DEMONSTRATED EVIDENCE OF A LARGE HEMOPERICARDIUM. THE PATIENT TOLERATED THE LARGE PERICARDIAL EFFUSION FOR 16 DAYS AND THEN ACUTELY DEVELOPED SYMPTOMS OF TAMPONADE. THIS CASE REPORT FOCUSED ON THE DELAYED ONSET OF CARDIAC TAMPONADE, BUT THE FINDINGS OF SIGNIFICANT HEMOPERICARDIUM WERE PRESENT IMMEDIATELY AFTER RETRIEVAL OF THE FILTER AND IS DIRECTLY A RESULT OF RETRIEVING THE FILTER, AS RETRIEVAL CREATED A HOLE IN THE SVC CAUSING DEVELOPMENT OF THE HEMOPERICARDIUM. DUE TO HIGH COMPLICATION RATES GIVEN THE ANATOMY AND DESIGN OF THE FILTER CARDIAC TAMPONADE IS A WELL-DOCUMENTED RESULT OF OFF-LABEL USE OF IVC FILTERS IN SUPERIOR VENA CAVA. ACCORDING TO INSTRUCTIONS FOR USE (IFU) FOR TULIP FILTER PLACEMENT THE FILTER IS INTENDED FOR FILTRATION OF INFERIOR VENA CAVA (IVC) BLOOD TO PREVENT PULMONARY EMBOLISM. GUNTHER TULIP FILTER RETRIEVAL SETS IFU: THE PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. BASED ON THE AVAILABLE INFORMATION THE EXACT CAUSE OF THE REPORTED ISSUE IS NOT CLEAR AND IS POSSIBLY CONTRIBUTED TO BY THE PATIENT¿S CLINICAL CONDITION AND/OR, PHYSICIAN PROCEDURE/TECHNIQUE, AND/OR THE MALFUNCTION OF THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE RETRIEVAL DEVICE DID NOT PERFORM AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED IN THE JOURNAL ARTICLE: "DELAYED CARDIAC TAMPONADE FOLLOWING INJURY DURING RETRIEVAL OF A SUPERIOR VENA CAVAL FILTER", PRASAD S. DALVIE, MD NARENDRA BABU GUTTA, MBBS VOL. 26 N. 26 JUNE 2015, PG. 929-930. "SIXTEEN DAYS AFTER FILTER RETRIEVAL (VIA GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET), THE PATIENT ACUTELY DEVELOPED SHORTNESS OF BREATH AND HYPOTENSION. ECHOCARDIOGRAPHY SHOWED CARDIAC TAMPONADE PHYSIOLOGY INDICATED BY DIASTOLIC COLLAPSE OF THE RIGHT ATRIUM AND VENTRICLE. EMERGENT PERICARDIOCENTESIS WAS PERFORMED, WITH EVACUATION OF 1,200 ML OF BLOOD AND PERICARDIAL DRAIN PLACEMENT FOR 48 HOURS. THIS RESULTED IN RAPID SYMPTOMATIC IMPROVEMENT. THE PATIENT WAS DISCHARGED HOME AFTER 34 DAYS FOLLOWING TREATMENT FOR PANCREATITIS AND HAD NO RECURRENT CARDIAC SYMPTOMS IN THE FOLLOWING YEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857595 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R