BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 4696970 · Received April 15, 2015

    Report

    Report Number
    3002808486-2015-00037
    Event Type
    Injury
    Date Received
    April 15, 2015
    Date of Event
    December 17, 2014
    Report Date
    January 12, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER RE-EVALUATION OF PERFORATION, THE DECISION IS CONSIDERED AS NOT LIFE-THREATENING TO THE PATIENT (CHANGED FROM GRADE 3 PERFORATION TO GRADE 2). CATALOG # IGTCFS-65-FEM-CELECT-PERM. SUMMARY OF INVESTIGATIONAL FINDINGS: RE-EVALUATION OF IMAGING REVELED NO GRADE 3 PERFORATION. PATIENT'S FILTER RETRIEVED ON (B)(6) 2014. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS BASED ON THE DESCRIPTION OF THE EVENT AND THE CORE LAB FINDINGS. CORE LAB ANALYSIS OF THE ULTRASOUND REVEALED NO THROMBUS IN THE INFERIOR VENA CAVA (IVC), THE PELVIC VEINS, OR THE LOWER EXTREMITY VEINS. THE X-RAY REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION OR MIGRATION. THE FILTER TILT WAS LESS THAN 6 DEGREES. CORE LAB ANALYSIS OF THE PRE-RETRIEVAL X-RAY REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, OR MIGRATION. HOWEVER, CORE LAB NOTED EVIDENCE OF FILTER DEFORMATION, SPECIFICALLY AN UNEVEN DISTRIBUTION OF THE FILTER LEGS: "ONE OF THE FILTER STRUTS IS CLEARLY BENT AND ABUTTING THE RIGHT RENAL URETEROPELVIC JUNCTION (SEE AP EXAM)." THE ANGLE OF TILT WAS 9.4 DEGREES IN THE AP VIEW AND 8.2 DEGREES IN THE LAT VIEW. CORE LAB READ OF CHEST AND ABDOMINAL CT INDICATES A GRADE 3 FILTER LEG INTERACTION WITH IVC WALL AND RETROPERITONEUM. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. THERE IS 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    POST MARKET STUDY: ON (B)(6) 2014 (226 DAYS POST-PROCEDURE), THE PATIENT HAD THE PRE-RETRIEVAL CHEST AND ABDOMINAL CT WITH CONTRAST, ULTRASOUND, AND X-RAY PERFORMED. THE CT WAS NEGATIVE FOR PULMONARY EMBOLISM. A GRADE 2 FILTER LEG INTERACTION WITH THE IVC WAS OBSERVED, BUT IT DID NOT RESULT IN CLINICAL SEQUELAE THAT REQUIRED INTERVENTION OR TREATMENT. THE ULTRASOUND REVEALED NO THROMBUS IN THE INFERIOR VENA CAVA (IVC), THE PELVIC VEINS, OR THE LOWER EXTREMITY VEINS. ON (B)(6) 2014 (232 DAYS POST-PROCEDURE), THE FILTER WAS ENDOVASCULARLY RETRIEVED WITH A GUNTHER TULIP RETRIEVAL SET, VIA THE RIGHT INTERNAL JUGULAR VEIN, BECAUSE IT WAS NO LONGER CLINICALLY NEEDED. FILTER LEGS DID NOT APPEAR OUTSIDE THE COLUMN OF CONTRAST BEFORE FILTER RETRIEVAL. THERE WAS NO THROMBUS PRESENT IN THE FILTER, AND THE LEVEL OF DIFFICULTY WAS RATED MODERATE. THERE WAS NO EXTRAVASATION OF CONTRAST AFTER THE FILTER RETRIEVAL. THE PATIENT WAS ON ASPIRIN PRIOR TO FILTER RETRIEVAL.

    Description of Event or Problem · 1

    POST MARKET STUDY: ON (B)(6) 2014 (226 DAYS POST-PROCEDURE), THE PATIENT HAD THE PRE-RETRIEVAL CHEST AND ABDOMINAL CT WITH CONTRAST, ULTRASOUND, AND X-RAY PERFORMED. THE CT WAS NEGATIVE FOR PULMONARY EMBOLISM. A GRADE 2 FILTER LEG INTERACTION WITH THE IVC WAS OBSERVED, BUT IT DID NOT RESULT IN CLINICAL SEQUELAE THAT REQUIRED INTERVENTION OR TREATMENT. THE ULTRASOUND REVEALED NO THROMBUS IN THE INFERIOR VENA CAVA (IVC), THE PELVIC VEINS, OR THE LOWER EXTREMITY VEINS. ON (B)(6) 2014 (232 DAYS POST-PROCEDURE), THE FILTER WAS ENDOVASCULARLY RETRIEVED WITH A GUNTHER TULIP RETRIEVAL SET, VIA THE RIGHT INTERNAL JUGULAR VEIN, BECAUSE IT WAS NO LONGER CLINICALLY NEEDED. FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST BEFORE FILTER RETRIEVAL. THERE WAS NO THROMBUS PRESENT IN THE FILTER, AND THE LEVEL OF DIFFICULTY WAS RATED MODERATE. THERE WAS NO EXTRAVASATION OF CONTRAST AFTER THE FILTER RETRIEVAL. THE PATIENT WAS ON ASPIRIN PRIOR TO FILTER RETRIEVAL. PATIENT OUTCOME: PATIENT'S FILTER RETRIEVED ON (B)(6) 2014 AND NO SYMPTOMS WERE REPORTED RELATED TO THE ONE IVC FILTER LEG WITH GRADE 3 INTERACTION NOTED ON PRE-RETRIEVAL IMAGING ADDITIONAL INFORMATION: INSTEAD OF 1 IVC FILTER LEG AT GRADE 3, NOW ZERO LEGS AT GRADE 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250907 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3183087

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Life Threatening