BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 11973112 · Received June 10, 2021

    Report

    Report Number
    3002808486-2021-01327
    Event Type
    Death
    Date Received
    June 10, 2021
    Report Date
    July 6, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ACCORDING TO THE ARTICLE THE IVC-FILTER WAS PLACED IN THE SUPERIOR VC BY MEANS OF A FEMORAL ACCESS KIT USED FOR JUGULAR ACCESS DUE TO CONTRAINDICATION OF ANTICOAGULATION THERAPY. THE PATIENT¿S CONDITION DETERIORATED IN THE FOLLOWING WEEKS MAINLY DUE TO GRADUAL WORSENING OF RESPIRATORY AND CARDIAC STATUS WITH PERSISTENT HYPOXEMIA AND BRADYCARDIA. THE PATIENT DIED 15 DAYS AFTER THE FILTER IMPLANT. THE EXACT CAUSE OF DEATH IS NOT STATED IN THE REPORT. THE IMPLANTATION OF THE IVC FILTER IN THE SVC REPRESENTS OFF-LABEL USE WHICH IS ALSO MENTIONED IN THE CASE REPORT. THE FACT THAT THE IMPLANTATION OF THE FILTER WAS ACHIEVED BY MEANS OF A FEMORAL ACCESS KIT USED THROUGH A JUGULAR ACCESS SITE ALSO REPRESENTS OFF-LABEL USE OF THE DELIVERY SYSTEM. HOWEVER, THE EXACT CAUSE OF DEATH IS NOT STATED IN THE REPORT AND CONSEQUENTLY, IT CANNOT BE DETERMINED IF THE FILTER HAD ANY IMPACT ON THE DETERIORATION IN THE PATIENT¿S HEALTH DURING THE FILTER IMPLANT TIME AND/OR ON THE DEATH 15 DAYS AFTER THE FILTER PLACEMENT. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT PLATINUM FILTER. SIMILAR TO DEVICE UNDER. PMA/510(K): K171712. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AFTER THE NEUROSURGICAL PROCEDURE AND THE ¿OFF-LABEL¿ FILTER PLACEMENT IN THE SUPERIOR VENA CAVA, THE CLINICAL STATUS OF THE PATIENT (MAINLY RESPIRATORY AND CARDIAC STATUS) WORSENED PROGRESSIVELY, PREVENTING ANY FURTHER INTERVENTIONAL PROCEDURES. THE PATIENT SUFFERED PERSISTENT HYPOXEMIA AND BRADYCARDIA THROUGHOUT THE TIME IN HOSPITAL AND DIED 15 DAYS AFTER THE FILTER HAD BEEN PLACED. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE AN ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875224 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death