BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MEDICAL CELECT VENA CAVA FILTER

    MDR report key: 13579454 · Received February 18, 2022

    Report

    Report Number
    MW5107597
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    February 20, 2020
    Report Date
    June 6, 2022
    Manufacturer
    COOK MEDICAL LLC.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6). (15 TYPEWRITTEN PAGES--FAR EXCEEDS 4000 CHARACTERS). FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    (B)(6). (15 TYPEWRITTEN PAGES--FAR EXCEEDS 4000 CHARACTERS). FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER FOR REPORT NUMBER MW5107597. REPORTER CALLING TO PROVIDE FURTHER INFORMATION ON A REPORT PREVIOUSLY SUBMITTED, INCLUDING EXPLANT DATE. HE STATES THAT ON 20-FEB-2020, HE WOKE UP WITH DIFFICULTY BREATHING; AFTER SEEING HIS DOCTOR'S OFFICE THE SAME DAY IT WAS DETERMINED HE HAD BILATERAL PULMONARY EMBOLISM. OF NOTE, REPORTER STATES TWO DAYS PRIOR, ON 18-FEB-2020, HE HAD A CT SCAN THAT SHOWED HIS BLOOD CLOT HAD SUBSTANTIALLY GROWN IN SIZE. WHEN HE WENT TO THE HOSPITAL ON 20-FEB-2020, REPORTER STATES HIS LOCAL HOSPITAL WAS UNABLE TO TREAT THE SERIOUSNESS OF HIS CONDITION, SO HE WAS TRANSFERRED TO A LARGER MEDICAL FACILITY. ON 21-FEB-2020, HAD EKOS PROCEDURE TO REMOVE BLOOD CLOTS; HE CREDITS THIS PROCEDURE WITH SAVING HIS LIFE. HE STATES THIS DEVICE WAS EXPLANTED ON (B)(6) 2022. HE IS FILING THIS REPORT WITH THE FDA BECAUSE HE IS UNSURE IF HIS LOCAL HOSPITAL EVER SUBMITTED A REPORT REGARDING THIS ADVERSE EVENT. HE STATES HE HAS ALSO REPORTED THIS ADVERSE EVENT TO THE DEVICE MANUFACTURER, COOK MEDICAL LLC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882369 COOK MEDICAL CELECT VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC. G34505 E3901455

    Patients

    Seq Age Sex Outcome Treatment
    1 76 DA Male Hospitalization| R| L ALLEGRA 180 MG AM| ANTIVERT 25 MG PM| ASPIRIN 81 MG PM| CALCIUM CITRATE + D3 VITAMIN D3 250 IU/CALCIUM 200 MG AM| DYAZIDE 25 MG/37.5 MG AM| FIBER CAPSULES 5 CAPSULES (2 G FIBER) 3X| FLOMAX 0.4 MG TWICE PER DAY| FLONASE 50 MCG NASAL SPRAY TWO SPRAYS IN EACH NOSTRIL AM| GLUCOSAMINE-CHONDROITIN 1500 MG/1200 MG TWICE PER DAY| POTASSIUM GLUCONATE 595 MG (99 MG POTASSIUM) PM