BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 6398523 · Received March 13, 2017

    Report

    Report Number
    3002808486-2017-00762
    Event Type
    Death
    Date Received
    March 13, 2017
    Report Date
    March 21, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER) G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING ¿IVC FILTER - DEATH, PAIN, DIFFICULT BREATHING". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. UNKNOWN IF REPORTED PATIENT DEATH IS RELATED TO FILTER. UNKNOWN IF REPORTED PATIENT DEATH IS RELATED TO FILTER. UNKNOWN IF THE REPORTED PAIN AND DIFFICULTY BREATHING ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. FILTER TYPE, RPN AND LOT# ARE UNKNOWN. 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. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Additional Manufacturer Narrative · 1

    (B)(4). WILLIAM COOK EUROPE IS NOT ASSUMING RESPONSIBILITY FOR PATIENT DEATH, UNCLEAR THE REASON FOR DEATH. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH AN IVC FILTER AND SUFFERED PRE-DEATH INJURIES AND/OR DEATH." PATIENT OUTCOME: ALLEGED THAT [PT] "HAS SUFFERED PERMANENT AND CONTINUOUS INJURIES, PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT. [PT] HAS SUFFERED EMOTIONAL TRAUMA, HARM AND INJURIES THAT WILL CONTINUE INTO THE FUTURE. [PT] HAS LOST THEIR ABILITY TO LIVE A NORMAL LIFE, AND WILL CONTINUE TO BE SO DIMINISHED INTO THE FUTURE. FURTHERMORE, [PT] HAS LOST EARNINGS AND WILL CONTINUE TO LOSE EARNINGS INTO THE FUTURE AND HAVE MEDICAL BILLS BOTH PAST AND FUTURE RELATED TO CARE BECAUSE OF THE IVC FILTERS¿ DEFECTS." [PT] IS DECEASED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 30JAN2018 AS FOLLOWS: PT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2008 VIA THE GROIN DUE TO BLOOD CLOTS. PT REPORTED TO HAVE EXPIRED ON (B)(6) 2008 WITHOUT FURTHER DETAILS. PT'S ESTATE FURTHER ALLEGES CHEST AND LEG PAIN, DIFFICULTY BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181843 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death