BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 1931966 · Received December 17, 2010

    Report

    Report Number
    9610978-2010-00261
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) LATER, THE FILTER WAS OBSERVED TO BE FULLY EXPANDED AND THE NARROWED SECTION OF THE VESSEL COULD NOT BE SEEN ANYMORE PRIOR TO THE SECOND PROCEDURE. A 10F TERUMO SHEATH INTRODUCER WAS INSERTED VIA THE RIGHT FEMORAL VEIN FOR THE FILTER RETRIEVAL. THE FILTER WAS SNARED (15MM GOOSE NECK SNARE) AND PULLED DOWN BUT IT HARDLY MOVED. A 10F BRITETIP GUIDING CATHETER ((B)(4)) WAS USED TO WITHDRAW BUT ATTEMPTS WERE UNSUCCESSFUL. AT THIS TIME THE SAME THING OCCURRED, THE FILTER WAS NOT FULLY EXPANDED AND THE NARROWED IVC WERE SEEN AGAIN. THE PHYSICIAN THOUGHT THAT THE FILTER WAS POSSIBLY CAUGHT IN THE IVC AND ATTEMPTED TO SEPARATE THE DEVICE FROM THE VESSEL USING AN 8F BRITETIP SHEATH INTRODUCER AND A 6F CATHETER VIA THE RIGHT JUGULAR VEIN; HOWEVER, ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN BECAME CONCERNED THAT ENDOTHELIALIZATION MAY HAVE OCCURRED; THEREFORE, THE DECISION WAS MADE TO DISCONTINUE THE PROCEDURE AND LEAVE THE FILTER PERMANENTLY IMPLANTED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(6) OPTEASE IVC FILTER, CATALOG 466F220AJ, IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED OPTEASE PRODUCT.

    Additional Manufacturer Narrative · 1

    HISTORY: THIS COMPLAINT INVOLVES A (B)(6) PREGNANT PATIENT, WHO HAD AN OPTEASE IVC FILTER PLACED VIA A JUGULAR VEIN APPROACH. INDICATION FOR FILTER PLACEMENT WAS DVT. THE PATIENT DELIVERED HER BABY UNEVENTFULLY. COUMADIN WAS STARTED AFTER THE DELIVERY. (B)(6) DAYS AFTER FILTER PLACEMENT AN ATTEMPT WAS MADE TO RETRIEVE THE FILTER. AT THAT TIME THE PHYSICIAN NOTED A SMALL AMOUNT OF THROMBUS AT BOTH ENDS OF THE FILTER. DURING ATTEMPTED RETRIEVAL, THE PHYSICIAN EXPERIENCED "FRICTION" AFTER 2/3 OF THE FILTER HAD BEEN CAPTURED. THE PATIENT EXPERIENCED PAIN AND THE WITHDRAWAL WAS STOPPED. THE FILTER WAS REDEPLOYED. (B)(6) DAYS LATER A SECOND ATTEMPT WAS MADE TO WITHDRAW THE FILTER. THIS WAS ALSO UNSUCCESSFUL. THE FILTER WAS THEN LEFT PERMANENTLY IMPLANTED. OBSERVATIONS: INITIAL IMAGES DEMONSTRATE INITIAL FILTER PLACEMENT VIA JUGULAR VEIN APPROACH. IVC VENOGRAM SHOWS NORMAL IVC ANATOMY AND WELL DELINEATES THE RENAL VEINS BILATERALLY. THE FILTER IS DEPLOYED IN THE SUPRARENAL IVC. I ASSUME THAT THIS TARGET SITE WAS CHOSEN DUE TO THE FULL TERM PREGNANCY. POST DEPLOYMENT, THE FILTER IS FULLY EXPANDED AND IS UNREMARKABLE. SUBSEQUENT IMAGES ARE FROM ATTEMPTED REMOVAL. VENOGRAM PERFORMED FROM THE FEMORAL VEIN APPROACH SHOWS A SMALL AMOUNT OF THROMBUS AT THE SUPERIOR AND INFERIOR CONES OF THE FILTER. THE FILTER IS ALMOST COMPLETELY CAPTURED INTO A SHEATH. THE FILTER IS THEN PARTIALLY RELEASED AND A VENOGRAM SHOWS NARROWING OF THE IVC AT THE LEVEL OF THE SUPERIOR CONE (THE PART THAT COULD NOT BE CAPTURED INTO THE SHEATH). THIS NARROWING IS CONTIGUOUS WITH THE FILTER. THIS MAY REPRESENT ENDOTHELIALIZATION OR ORGANIZED THROMBUS AT THE LEVEL OF THE SUPERIOR CONE. CT PERFORMED AT THIS TIME DOES NOT HAVE CONTRAST IN THE IVC. I CANNOT ASSESS FOR THE PRESENCE OR ABSENCE OF IVC THROMBUS. THE FILTER IS WELL EXPANDED IN THE SUPRARENAL IVC. NO RETROPERITONEAL FLUID COLLECTION IS SEEN. IMAGES FROM THE SECOND RETRIEVAL ATTEMPT ARE NOT PROVIDED. CONCLUSION: THIS COMPLAINT INVOLVES A (B)(6) POST PARTUM FEMALE. AN OPTEASE IVC WAS UNABLE TO BE RETRIEVED (B)(6) DAYS AFTER IMPLANTATION. THIS REQUIRED THE TREATING PHYSICIAN TO LEAVE THE FILTER IN PERMANENTLY. FROM THE IMAGES AND CLINICAL INFORMATION PROVIDED IT APPEARS THAT EARLY ENDOTHELIALIZATION OF THE FILTER AT THE LEVEL OF THE SUPERIOR CONE MAY HAVE OCCURRED. THIS ATTEMPTED RETRIEVAL WAS OUTSIDE OF THE 12 DAY WINDOW AS PER THE IFU. ALTERNATIVELY, THIS MAY REPRESENT ORGANIZED THROMBUS FIXING THE FILTER TO THE VESSEL WALL. THE PATIENT EXPERIENCED PAIN UPON ATTEMPTED RETRIEVAL AND THE VENOGRAM WAS CLEARLY ABNORMAL. THE TREATING PHYSICIAN RESPONDED CORRECTLY BY ABORTING THE RETRIEVAL PROCEDURE. GREAT CARE MUST BE TAKEN DURING OPTIONAL FILTER RETRIEVAL. IF RESISTANCE IS ENCOUNTERED, CAUTION MUST BE TAKEN AS THIS CAN RESULT IN CAVAL LACERATION. FROM THE IMAGES AND CLINICAL INFORMATION PROVIDED, THERE WAS NO APPARENT DIFFICULTY OR PROBLEM DURING IMPLANTATION. ALTHOUGH A VERY UNUSUAL EVENT, I BELIEVE THAT THIS CASE REPRESENTS VERY EARLY INCORPORATION OF THE FILTER INTO THE VESSEL WALL; EITHER BY ENDOTHELIALIZATION OR BY ORGANIZED THROMBUS. THE ATTEMPTED RETRIEVAL WAS AFTER THE 12 DAY LIMIT AS PER THE PRODUCT IFU. I HAVE NO EVIDENCE TO CORRELATE THIS CLINICAL EVENT WITH PRODUCT MALFUNCTION OR MANUFACTURING ISSUES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY PATIENT AND PROCEDURAL FACTORS AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    INCOMPLETE EXPANSION, RETRIEVAL DIFFICULTY, THROMBOSIS IN DEVICE, SUPERIOR VENA CAVAL STENOSIS. THE TARGET LESION WAS INFERIOR VENA CAVA (ABOVE RENAL VEIN). THE PATIENT WAS A (B)(6) WOMAN. NO CALCIFICATION AND NO VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 0%. AN OPTEASE FILTER PLACEMENT FOR DVT (COMPLAINT PRODUCT) WAS SUCCESSFULLY CONDUCTED VIA THE JUGULAR VEIN. THE FOLLOWING DAY, THE PATIENT DELIVERED A BABY. WARFARIN POTASSIUM 4MMG HAS BEEN ADMINISTERED SINCE THE DELIVERY. (B)(6) AFTER PLACEMENT OF THE OPTEASE FILTER A SMALL AMOUNT OF THROMBUS WAS OBSERVED AT THE TOP AND BOTTOM OF THE FILTER. FILTER RETRIEVAL WAS CONDUCTED VIA THE RIGHT FEMORAL VEIN. THE FILTER WAS RETRIEVED WITH 6F GOOSE NECK SNARE (15MM DIAMETER, EV3) BUT FRICTION/RESISTANCE OCCURRED WHEN TWO-THIRDS OF THE FILTER HAD BEEN WITHDRAWN INTO THE 10F BRITETIP GUIDING CATHETER (80CM). THE DEVICES WERE MOVED DOWN TOGETHER BUT THE PATIENT COMPLAINED OF THE PAIN. THE FILTER WAS THEN REPLACED IN THE TARGET LESION; HOWEVER, THE FILTER DID NOT FULLY EXPAND. ANGIOGRAPHY REVEALED A NARROWING OF THE VENA CAVA JUST ABOVE THE RIGHT RENAL VEIN. THE PROCEDURE WAS DISCONTINUED AND WAS RESCHEDULED FOR ANOTHER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R 6F GOOSE NECK SNARE, 10F BRITETIP GUIDING CATHETER