BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4895945 · Received July 7, 2015

    Report

    Report Number
    9616099-2015-00278
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    October 29, 2014
    Report Date
    July 24, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TYPES OF FILTERS USED WERE GUNTER TULIP (COOK MEDICAL INC. (B)(4)) IN 75 CASES, CELECT (COOK MEDICAL INC.) IN 39 CASES, AND OPTEASE (CORDIS, (B)(4)) IN 2 CASES. THE LOCATIONS OF THE FILTERS WERE INFRARENAL IVC IN 105 CASES (91.3%) AND SUPRARENAL IVC IN 11 CASES (9.6%). IVCF PLACEMENT WAS DONE IN 115 CASES (113 PATIENTS). THERE WERE 68 MEN (59.1%), AND THE MEAN AGE WAS 58.5±15.5 YEARS (RANGE, 10-96 YEARS). THE AFFILIATED DEPARTMENTS WERE VASCULAR SURGERY (57 CASES, 49.6%), AND INTERNAL MEDICINE (20 CASES, 17.4%). ADVANCED MALIGNANCY WAS THE MOST COMMONLY ASSOCIATED DISEASE (N=30, 26%). THE INDICATIONS FOR IVCF PLACEMENT WERE CATEGORIZED; ABSOLUTE INDICATIONS IN 36 CASES (31.3%), RELATIVE INDICATIONS IN 78 CASES (67.8%), AND PROPHYLACTIC USE IN 1 CASE (0.9%). THE MOST COMMON INDICATIONS WERE THROMBOLYSIS/THROMBECTOMY FOR ILIOCAVAL DEEP VEIN THROMBOSIS (DVT) (N=55, 47.8). OF THE 115 FILTERS, 68 WERE RETRIEVED (RETRIEVAL RATE, 59%). THE MOST COMMON CAUSE OF NON-RETRIEVAL WAS CHRONIC HIGH RISK OF VENOUS THROMBOEMBOLISM IN 24 PATIENTS (51%), FOLLOWED BY RESIDUAL PROXIMAL DVT (N=7, 15%), AND NEGLIGENCE BY UNKNOWN REASONS (N=6, 13%). (B)(6). THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS: PARK ET AL CURRENT STATUS OF THE RETRIEVAL RATE OF RETRIEVABLE VENA CAVA FILTERS IN A TERTIARY REFERRAL CENTER IN (B)(6), VASCULAR SPECIALIST INTERNATIONAL 30 (2014) 133-138. A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. AS NOTED IN THE PUBLICATION BY PARK ET AL CURRENT STATUS OF THE RETRIEVAL RATE OF RETRIEVABLE VENA CAVA FILTERS IN A TERTIARY REFERRAL CENTER IN (B)(6), VASCULAR SPECIALIST INTERNATIONAL 30 (2014) 133-138; ONE PATIENT WITH FILTER-RELATED IVC THROMBOSIS WAS TRANSFERRED FROM A REGIONAL HOSPITAL, AND THROMBOLYSIS WAS PERFORMED WITH A RETRIEVABLE SUPRARENAL FILTER. THE PATIENT HAD TWO OPTEASE FILTERS, ONE LOCATED IN THE INFRARENAL IVC AND ONE IN THE SUPRARENAL IVC. AFTER THROMBOLYSIS, THE SUPRARENAL VENA CAVA WAS PATENT, BUT THE INFRARENAL VENA CAVA HAD REMAINING THROMBUS WITH STENOSIS NEAR THE INFRARENAL FILTER. ONLY THE SUPRARENAL FILTER WAS RETRIEVED. THE FILTER WAS RETRIEVED WITH A METICULOUS TECHNIQUE WITHOUT COMPLICATIONS. ADDITIONAL PROCEDURAL DETAILS COULD NOT BE OBTAINED. THE PURPOSE OF THIS STUDY WAS TO REVIEW THE DAILY PRACTICE OF INFERIOR VENA CAVA FILTERS (IVCFS) IN A TERTIARY REFERRAL CENTER IN (B)(6) AND TO REVEAL THE RETRIEVAL RATE AND THE METHODS FOR IMPROVING IT. THROUGH THE ELECTRONIC MEDICAL RECORD SYSTEM, A RETROSPECTIVE REVIEW WAS PERFORMED ON 115 CONSECUTIVE PATIENTS WHO UNDERWENT PLACEMENT OF RETRIEVABLE IVCFS BETWEEN (B)(6) 2000 AND (B)(6) 2011 IN (B)(6) HOSPITAL. THE TYPES OF FILTERS USED WERE GUNTER TULIP (COOK MEDICAL INC., (B)(4)) IN 75 CASES, CELECT (COOK MEDICAL INC.) IN 39 CASES, AND OPTEASE (CORDIS, (B)(4)) IN 2 CASES. THE LOCATIONS OF THE FILTERS WERE INFRARENAL IVC IN 105 CASES (91.3%) AND SUPRARENAL IVC IN 11 CASES (9.6%). IVCF PLACEMENT WAS DONE IN 115 CASES (113 PATIENTS). THERE WERE 68 MEN (59.1%), AND THE MEAN AGE WAS 58.5±15.5 YEARS (RANGE, 10-96 YEARS). THE AFFILIATED DEPARTMENTS WERE VASCULAR SURGERY (57 CASES, 49.6%), AND INTERNAL MEDICINE (20 CASES, 17.4%). ADVANCED MALIGNANCY WAS THE MOST COMMONLY ASSOCIATED DISEASE (N=30, 26%). THE INDICATIONS FOR IVCF PLACEMENT WERE CATEGORIZED; ABSOLUTE INDICATIONS IN 36 CASES (31.3%), RELATIVE INDICATIONS IN 78 CASES (67.8%), AND PROPHYLACTIC USE IN 1 CASE (0.9%). THE MOST COMMON INDICATIONS WERE THROMBOLYSIS/THROMBECTOMY FOR ILIOCAVAL DEEP VEIN THROMBOSIS (DVT) (N=55, 47.8). OF THE 115 FILTERS, 68 WERE RETRIEVED (RETRIEVAL RATE, 59%). THE MOST COMMON CAUSE OF NON-RETRIEVAL WAS CHRONIC HIGH RISK OF VENOUS THROMBOEMBOLISM IN 24 PATIENTS (51%), FOLLOWED BY RESIDUAL PROXIMAL DVT (N=7, 15%), AND NEGLIGENCE BY UNKNOWN REASONS (N=6, 13%). THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBERS. THE IFU OF THE OPTEASE RETRIEVABLE FILTER IS INDICATED FOR RETRIEVAL UP TO 12 DAYS AFTER PLACEMENT AND IS CONSIDERED A PERMANENT IMPLANT IF IT IS NOT RETRIEVED WITHIN THE SPECIFIED TIME PERIOD. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THROMBUS IN THE FILTER DOES NOT REPRESENT A DEVICE MALFUNCTION. THROMBOSIS IN THE FILTER IS A WELL KNOWN POTENTIAL COMPLICATION AND OCCURS IN APPROXIMATELY 3.6 TO 11.2 % OF ALL PATIENTS¿. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. IVC STENOSIS IS A RARE ANOMALY THAT HAS BEEN ASSOCIATED WITH IVC THROMBOSIS (ALKHOULI ET AL INFERIOR VENA CAVA FILTER THROMBOSIS AND SUPRARENAL CAVAL STENOSIS; JACC CARDIOVASCULAR INTERVENTIONS, VOLUME 8 NO 2, 2015). WITHOUT THE LOT NUMBERS TO CONDUCT DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2015-00277 AND 9616099-2015-00278.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED TO REMOVE THE PATIENT CODE OF (B)(4) AS THERE WAS NO STENOSIS OF THE FILTER. THE PREVIOUSLY REPORTED CONCLUSION IS ALSO MODIFIED TO UPDATE PARAGRAPH THREE. AS NOTED IN THE PUBLICATION BY (B)(6) ET AL CURRENT STATUS OF THE RETRIEVAL RATE OF RETRIEVABLE VENA CAVA FILTERS IN A TERTIARY REFERRAL CENTER IN (B)(6) , VASCULAR SPECIALIST INTERNATIONAL (B)(6) (2014) (B)(6) ; ONE PATIENT WITH FILTER-RELATED IVC THROMBOSIS WAS TRANSFERRED FROM A REGIONAL HOSPITAL, AND THROMBOLYSIS WAS PERFORMED WITH A RETRIEVABLE SUPRARENAL FILTER. THE PATIENT HAD TWO OPTEASE FILTERS, ONE LOCATED IN THE INFRARENAL IVC AND ONE IN THE SUPRARENAL IVC. AFTER THROMBOLYSIS, THE SUPRARENAL VENA CAVA WAS PATENT, BUT THE INFRARENAL VENA CAVA HAD REMAINING THROMBUS WITH STENOSIS NEAR THE INFRARENAL FILTER. ONLY THE SUPRARENAL FILTER WAS RETRIEVED. THE FILTER WAS RETRIEVED WITH A METICULOUS TECHNIQUE WITHOUT COMPLICATIONS. ADDITIONAL PROCEDURAL DETAILS COULD NOT BE OBTAINED. THE PURPOSE OF THIS STUDY WAS TO REVIEW THE DAILY PRACTICE OF INFERIOR VENA CAVA FILTERS (IVCFS) IN A TERTIARY REFERRAL CENTER IN (B)(6) AND TO REVEAL THE RETRIEVAL RATE AND THE METHODS FOR IMPROVING IT. THROUGH THE ELECTRONIC MEDICAL RECORD SYSTEM, A RETROSPECTIVE REVIEW WAS PERFORMED ON (B)(4) CONSECUTIVE PATIENTS WHO UNDERWENT PLACEMENT OF RETRIEVABLE IVCFS BETWEEN (B)(6) 2000 AND (B)(6) 2011 IN (B)(6) HOSPITAL. THE TYPES OF FILTERS USED WERE GUNTER TULIP ((B)(4)) IN (B)(4) CASES, CELECT ((B)(4)) IN (B)(4) CASES, AND OPTEASE ((B)(4)) IN (B)(4) CASES. THE LOCATIONS OF THE FILTERS WERE INFRARENAL IVC IN (B)(4) CASES (91.3%) AND SUPRARENAL IVC IN 11 CASES (9.6%). IVCF PLACEMENT WAS DONE IN (B)(4) CASES ((B)(4) PATIENTS). THERE WERE 68 MEN (59.1%), AND THE MEAN AGE WAS 58.5±15.5 YEARS (RANGE, 10-96 YEARS). THE AFFILIATED DEPARTMENTS WERE VASCULAR SURGERY (57 CASES, 49.6%), AND INTERNAL MEDICINE (20 CASES, 17.4%). ADVANCED MALIGNANCY WAS THE MOST COMMONLY ASSOCIATED DISEASE (N=30, 26%). THE INDICATIONS FOR IVCF PLACEMENT WERE CATEGORIZED; ABSOLUTE INDICATIONS IN 36 CASES (31.3%), RELATIVE INDICATIONS IN 78 CASES (67.8%), AND PROPHYLACTIC USE IN 1 CASE (0.9%). THE MOST COMMON INDICATIONS WERE THROMBOLYSIS/THROMBECTOMY FOR ILIOCAVAL DEEP VEIN THROMBOSIS (DVT) (N=55, 47.8). OF THE 115 FILTERS, 68 WERE RETRIEVED (RETRIEVAL RATE, 59%). THE MOST COMMON CAUSE OF NON-RETRIEVAL WAS CHRONIC HIGH RISK OF VENOUS THROMBOEMBOLISM IN 24 PATIENTS (51%), FOLLOWED BY RESIDUAL PROXIMAL DVT (N=7, 15%), AND NEGLIGENCE BY UNKNOWN REASONS (N=6, 13%). THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBERS. THE IFU OF THE OPTEASE RETRIEVABLE FILTER IS INDICATED FOR RETRIEVAL UP TO 12 DAYS AFTER PLACEMENT AND IS CONSIDERED A PERMANENT IMPLANT IF IT IS NOT RETRIEVED WITHIN THE SPECIFIED TIME PERIOD. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THROMBUS IN THE FILTER DOES NOT REPRESENT A DEVICE MALFUNCTION. THROMBOSIS IN THE FILTER IS A WELL KNOWN POTENTIAL COMPLICATION AND OCCURS IN APPROXIMATELY 3.6 TO 11.2 % OF ALL PATIENTS¿. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. WITHOUT THE LOT NUMBERS TO CONDUCT DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS AND (B)(4).

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY PARK ET AL CURRENT STATUS OF THE RETRIEVAL RATE OF RETRIEVABLE VENA CAVA FILTERS IN A TERTIARY REFERRAL CENTER IN (B)(6), VASCULAR SPECIALIST INTERNATIONAL 30 (2014) 133-138; ONE PATIENT WITH FILTER-RELATED IVC THROMBOSIS WAS TRANSFERRED FROM A REGIONAL HOSPITAL, AND THROMBOLYSIS WAS PERFORMED WITH A RETRIEVABLE SUPRARENAL FILTER. THE PATIENT HAD TWO OPTEASE FILTERS, ONE LOCATED IN THE INFRARENAL IVC AND ONE IN THE SUPRARENAL IVC. AFTER THROMBOLYSIS, THE SUPRARENAL VENA CAVA WAS PATENT, BUT THE INFRARENAL VENA CAVA HAD REMAINING THROMBUS WITH STENOSIS NEAR THE INFRARENAL FILTER. ONLY THE SUPRARENAL FILTER WAS RETRIEVED. THE FILTER WAS RETRIEVED WITH A METICULOUS TECHNIQUE WITHOUT COMPLICATIONS. ADDITIONAL PROCEDURAL DETAILS COULD NOT BE OBTAINED. THE PURPOSE OF THIS STUDY WAS TO REVIEW THE DAILY PRACTICE OF INFERIOR VENA CAVA FILTERS (IVCFS) IN A TERTIARY REFERRAL CENTER IN (B)(6) AND TO REVEAL THE RETRIEVAL RATE AND THE METHODS FOR IMPROVING IT. THROUGH THE ELECTRONIC MEDICAL RECORD SYSTEM, A RETROSPECTIVE REVIEW WAS PERFORMED ON 115 CONSECUTIVE PATIENTS WHO UNDERWENT PLACEMENT OF RETRIEVABLE IVCFS BETWEEN (B)(6) 2000 AND (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438027 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1