BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4865159 · Received June 24, 2015

    Report

    Report Number
    9616099-2015-00249
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    May 2, 2015
    Report Date
    July 22, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY J. LEE ET AL THE CIRSE RETRIEVABLE IVC FILTER REGISTRY: RETRIEVAL SUCCESS RATES IN PRACTICE, CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY (2015), THERE WERE DIFFICULTIES SNARING THE HOOK OF THE OPTEASE DUE TO TILT OF THE FILTER. ADDITIONAL MANEUVERS WERE REQUIRED. INFORMATION AVAILABLE SUGGESTS THAT FOUR CASES INVOLVED IMMOBILIZATION OF THE FILTER USING A SNARE, THREE REMOVED USING BUDDY-WIRE TECHNIQUE AND TWO CASES WHERE THE SHEATH WAS EXCHANGED FOR A LARGER SIZE. THE MEAN FILTER DWELL TIME WAS 34 DAYS. DUE TO THE NATURE OF THIS COMPLAINT, DEVICES WERE NOT RETURNED NOR WAS A STERILE LOT NUMBER AVAILABLE TO CONDUCT A DHR. WITHOUT RETURN OF THE DEVICES FOR ANALYSIS, THE REPORTED ¿FILTER ¿TILT¿ LEADING TO ¿RETRIEVAL DIFFICULTY-UNABLE TO ENGAGE HOOK¿ COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, FACTORS CONTRIBUTING TO THE FILTER TILT (VESSEL CHARACTERISTICS, PROCEDURAL FACTORS, TECHNIQUE) COULD NOT BE DETERMINED. THE MEAN FILTER DWELL TIME WAS 34 DAYS. THE INSTRUCTIONS FOR USE NOTES THAT THE OPTEASE RETRIEVABLE FILTER CAN BE RETRIEVED UP TO AND INCLUDING 12 DAYS AFTER PLACEMENT AND IS CONSIDERED A PERMANENT IMPLANT IF IT IS NOT RETRIEVED WITHIN THE SPECIFIED TIME PERIOD. WITHOUT A DHR, A CORRELATION TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. REVISED: AS NOTED IN THE PUBLICATION BY J. LEE ET AL THE CIRSE RETRIEVABLE IVC FILTER REGISTRY: RETRIEVAL SUCCESS RATES IN PRACTICE, CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY (2015); THERE WERE DIFFICULTIES SNARING THE HOOK DUE TO TILT OF THE FILTER. THE DATA SHOWS THAT IN 14 CASES OPTEASE FILTER REMOVAL REQUIRED EXTRA MANOEUVRES. IN 4 OF THESE CASES THE FILTER WAS MOBILISED WITH USING A SNARE, IN 3 THE FILTER WAS REMOVED USING BUDDY-WIRE TECHNIQUE. IN 2 CASES A LARGER SHEATH WAS USED. THE GROWTH IN IVC FILTER INSERTION HAS PREDOMINANTLY BEEN DUE TO THE INTRODUCTION OF RETRIEVABLE IVC FILTERS. CIRSE ESTABLISHED A REGISTRY OF RETRIEVABLE FILTER USE WITH THE PRIMARY AIM OF DETERMINING THE SUCCESS OF IVC FILTER RETRIEVAL AND ASSOCIATED COMPLICATIONS. A WEB-BASED ELECTRONIC REGISTRY WAS DEVISED AND HOSTED ON A WEBSITE LINKED TO THE CIRSE WEBSITE. DATA ENTRY WAS DESIGNED TO OCCUR AT THE DATE OF IVC FILTER RETRIEVAL AND DATA POINTS INCLUDED FILTER TYPE, THE INDICATION FOR FILTER INSERTION, THE ACCESS ROUTE USED, THE DWELL TIME, IVC IMAGING BEFORE RETRIEVAL, RETRIEVAL SUCCESS, ANY EXTRA MANEUVERS REQUIRED FOR RETRIEVAL, REASONS FOR FAILED RETRIEVAL, COMPLICATIONS, AND ANTICOAGULATION STATUS. THE FILTER TYPES USED INCLUDED THE CELECT FILTER (COOK MEDICAL) IN 182 PATIENTS, THE OPTEASE FILTER (CORDIS) IN 161,A LN (ALN) IN 120, GUNTHER TULIP (COOK MEDICAL) IN 98,G2 (BARD) IN 22, ECLIPSE (BARD) IN 19, RECOVERY (BARD) IN 13, OPTION (ANGIOTEC) IN 9, AND 4 FILTER TYPES WERE NOT RECORDED IN THE DATABASE. THE ACCESS ROUTE INCLUDED RIGHT INTERNAL JUGULAR VEIN IN 456 PATIENTS (73 %), RIGHT FEMORAL VEIN IN 150 (24 %), LEFT COMMON FEMORAL VEIN IN 13 (2 %), LEFT INTERNAL JUGULAR IN 4 (0.5 %), AND OTHER INSERTION ROUTES IN 5 (0.5 %). AT THE TIME OF FILTER RETRIEVAL, 141 PATIENTS (22 %) WERE ON WARFARIN THERAPY, 172 PATIENTS (28 %) WERE RECEIVING LOW MOLECULAR WEIGHT HEPARIN, 44 (7 %) WERE RECEIVING INTRAVENOUS HEPARIN, AND 26 (4 %) WERE RECEIVING OTHER FORMS OF ANTICOAGULATION. 219 (35 %) PATIENTS WERE NOT RECEIVING ANY FORM OF ANTICOAGULATION AND THERE WERE 26 (4 %) ENTRIES WITH MISSING DATA POINTS. FILTERS WERE SUCCESSFULLY RETRIEVED IN 576 OF 628 PATIENTS (92 %). THE MEAN DWELL TIME FOR FILTERS SUCCESSFULLY RETRIEVED WAS 85 DAYS (MEDIAN 38) VERSUS 145 DAYS (MEDIAN 68) FOR THOSE PATIENTS WHOSE FILTERS COULD NOT BE RETRIEVED. OVERALL, 44 OF THE 576 SUCCESSFUL RETRIEVALS REQUIRED AN EXTRA MANEUVER (8 %), 16 REMAINING UNSPECIFIED. IN THE FAILED FILTER RETRIEVAL GROUP (52 PATIENTS), EXTRA MANEUVERS WERE USED IN 9 PATIENTS IN AN ATTEMPT TO REMOVE FILTERS, WHILE 31 CASES DID NOT INDICATE WHETHER EXTRA MANEUVERS WERE REQUIRED OR NOT. THIS REPORT IS RELATED TO REPORT NUMBERS: 9616099-2015-00247, 9616099-2015-00251 & 9616099-2015-00248.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AND NO STERILE LOT NUMBER WAS AVAILABLE, THEREFORE NO PRODUCT ANALYSIS WILL BE DONE. PLEASE REFER TO THE ATTACHED LITERATURE ARTICLE. LITERATURE CITATION: LEE, M. J. ET AL. (2015). THE CIRSE RETRIEVABLE IVC FILTER REGISTRY: RETRIEVAL SUCCESS RATES IN PRACTICE. CARDIOVASCULAR INTERVENTIONAL RADIOLOGY, 1-6. DOI 10.1007/S00270-015-1112-5. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THIS MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS WITH NO KNOWN SPECIFIC DEMOGRAPHICS OR DEVICE SPECIFICS.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY J. LEE ET AL THE CIRSE RETRIEVABLE IVC FILTER REGISTRY: RETRIEVAL SUCCESS RATES IN PRACTICE, CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY (2015); THERE WERE DIFFICULTIES SNARING THE HOOK DUE TO TILT OF THE FILTER. THE DATA SHOWS THAT IN 14 CASES OPTEASE FILTER REMOVAL REQUIRED EXTRA MANOEUVRES. IN 4 OF THESE CASES THE FILTER WAS MOBILISED WITH USING A SNARE, IN 3 THE FILTER WAS REMOVED USING BUDDY-WIRE TECHNIQUE. IN 2 CASES A LARGER SHEATH WAS USED. CIRSE ESTABLISHED A REGISTRY OF RETRIEVABLE FILTER USE WITH THE PRIMARY AIM OF DETERMINING THE SUCCESS OF IVC FILTER RETRIEVAL AND ASSOCIATED COMPLICATIONS. DATA ENTRY WAS DESIGNED TO OCCUR AT THE DATE OF IVC FILTER RETRIEVAL AND DATA POINTS INCLUDED FILTER TYPE, THE INDICATION FOR FILTER INSERTION, THE ACCESS ROUTE USED, THE DWELL TIME, IVC IMAGING BEFORE RETRIEVAL, RETRIEVAL SUCCESS, ANY EXTRA MANEUVERS REQUIRED FOR RETRIEVAL, REASONS FOR FAILED RETRIEVAL, COMPLICATIONS, AND ANTICOAGULATION STATUS. THE ACCESS ROUTE INCLUDED RIGHT INTERNAL JUGULAR VEIN IN 456 PATIENTS (73 %), RIGHT FEMORAL VEIN IN 150 (24 %), LEFT COMMON FEMORAL VEIN IN 13 (2 %), LEFT INTERNAL JUGULAR IN 4 (0.5 %), AND OTHER INSERTION ROUTES IN 5 (0.5 %). AT THE TIME OF FILTER RETRIEVAL, 141 PATIENTS (22 %) WERE ON WARFARIN THERAPY, 172 PATIENTS (28 %) WERE RECEIVING LOW MOLECULAR WEIGHT HEPARIN, 44 (7 %) WERE RECEIVING INTRAVENOUS HEPARIN, AND 26 (4 %) WERE RECEIVING OTHER FORMS OF ANTICOAGULATION. 219 (35 %) PATIENTS WERE NOT RECEIVING ANY FORM OF ANTICOAGULATION AND THERE WERE 26 (4 %) ENTRIES WITH MISSING DATA POINTS. OVERALL, 44 OF THE 576 SUCCESSFUL RETRIEVALS REQUIRED AN EXTRA MANEUVER (8 %), 16 REMAINING UNSPECIFIED. IN THE FAILED FILTER RETRIEVAL GROUP (52 PATIENTS), EXTRA MANEUVERS WERE USED IN 9 PATIENTS IN AN ATTEMPT TO REMOVE FILTERS, WHILE 31 CASES DID NOT INDICATE WHETHER EXTRA MANEUVERS WERE REQUIRED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408347 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention