BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6377405 · Received March 3, 2017

    Report

    Report Number
    1820334-2017-00329
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    January 27, 2017
    Report Date
    September 27, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND IMAGE REVIEW WAS CONDUCTED DURING THE INVESTIGATION. A TULIP FILTER WAS PLACED WITH INSIGNIFICANT TILT IN AN INFRARENAL LOCATION. AFTER 394 DAYS THE FILTER WAS IN A STABLE POSITION WHEN COMPARED TO THE PLACEMENT, BUT THE FILTER HOOK DID ABUT THE IVC WALL, WHICH AGAIN MAY MAKE FUTURE FILTER RETRIEVAL DIFFICULT. ALSO, TWO PRIMARY FILTER LEGS DEMONSTRATED GRADE 2 INTERACTIONS WITH THE IVC WALL AND THE OTHER TWO PRIMARY LEGS DEMONSTRATED GRADE 1 INTERACTIONS. THERE IS NO EVIDENCE OF PERICAVAL STRANDING OR HAZINESS TO SUGGEST ACUTE INFLAMMATORY REACTION AND THERE IS NO COMMENT IN HE COMPLAINT REPORT REGARDING ANY SYMPTOMS RELATED TO THESE PENETRATIONS. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. 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. BASED ON THE INFORMATION PROVIDED, THE FILTER REMAINING IMPLANTED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE RISK ASSESSMENT, MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K072240. THE DEVICE HAS NOT RETURNED FOR EVALUATION. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT PARTICIPATION IN A GRADE 2 FILTER LEG INTERACTION WITH IVC WALL STUDY. ON (B)(6) 2015, DURING THE INDEX PROCEDURE, THE PATIENT HAD A GÜNTHER TULIP® FILTER PLACED. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 15.5 MM. THERE WAS NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. USING THE RIGHT INTERNAL JUGULAR VEIN AS THE ACCESS SITE, A GÜNTHER TULIP® FILTER WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PE. THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, MIGRATION, OR TILT. THERE WAS NO EXTRAVASATION OF CONTRAST AND NO FILTER LEGS APPEARED OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. CORE LAB ANALYSIS OF THE PLACEMENT PROCEDURE VENACAVAGRAM REVEALED NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. THE FILTER WAS PLACED IN THE IVC INFRARENAL SITE AND THE IVC DIAMETER WAS 15.3 MM. FILTER MIGRATION, EXTRAVASATION OF CONTRAST, DEFORMATION, TILT, OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER PLACEMENT WAS NOT ASSESSED. ON (B)(6) 2015, POST-PROCEDURE X-RAY SHOWED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, MIGRATION, OR TILT. CORE LAB: NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR EMBOLIZATION. FILTER MIGRATION WAS NOT ASSESSED. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 6.2 DEGREES AND 6.6 DEGREES IN THE LAT VIEW. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE 3 AND 6 MONTH FOLLOW-UP CALLS WERE COMPLETED AND NO ADVERSE EVENTS WERE REPORTED. ON (B)(6) 2016 (314 DAYS POST-PROCEDURE), THE PATIENT¿S WAS ASSESSED VIA ULTRASOUND FOR A DEEP VEIN THROMBOSIS. NO TREATMENT WAS REQUIRED. THE INVESTIGATOR DID NOT THINK THAT THE EVENT WAS RELATED TO THE STUDY DEVICE OR PROCEDURE; RATHER, RELATED IT TO THE PATIENT¿S PRE-EXISTING HISTORY OF DVT. SITE AND CORE LAB ANALYSIS OF THE ULTRASOUND IS NOT YET AVAILABLE. ON (B)(6) 2017 (394 DAYS POST-PROCEDURE), THE 12 MONTH FOLLOW-UP CLINICAL ASSESSMENT, CT OF THE ABDOMEN AND PELVIS WITH INTRAVENOUS CONTRAST, ULTRASOUND, AND X-RAY WERE COMPLETED. THE FILTER WAS NOT SCHEDULED TO BE RETRIEVED DUE TO AN ONGOING RISK FOR PE. THE CT REVEALED NO EVIDENCE OF FILTER EMBOLIZATION, AND A GRADE 2 FILTER LEG INTERACTION WITH THE IVC WALL. THE ULTRASOUND REVEALED NO THROMBUS IN THE IVC OR PELVIC VEINS. THROMBUS WAS PRESENT IN THE BILATERAL LOWER EXTREMITIES. THE X-RAY REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, MIGRATION, OR TILT. CORE LAB ANALYSIS OF THE 12 MONTH FOLLOW-UP CT, ULTRASOUND, AND X-RAY IS NOT YET AVAILABLE. THE PATIENT REMAINS IN THE STUDY, NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158567 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR