BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1822716 · Received September 1, 2010

    Report

    Report Number
    2015691-2010-13983
    Event Type
    Death
    Date Received
    September 1, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, IT WAS LEARNED ON (B)(6) 2011 THAT THE DEATH OF THIS PATIENT WAS NOT DUE TO A DEVICE MALFUNCTION. THE CAUSE OF DEATH PROVIDED WAS CARDIAC ARREST.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED, (B)(4). TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 08/03/2010 AND 08/10/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF DEATH REMAINS UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPONSE WAS RECEIVED FROM THE HEALTH CARE PROVIDER THAT INDICATED THE DEATH WAS DUE TO CARDIAC ARREST AND NOT DUE TO A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.97 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    PER DISCHARGE SUMMARY: THIS IS A (B)(6) MAN WHO HAS A HISTORY OF CORONARY ARTERY DISEASE, WHO UNDERWENT CARDIAC SURGERY (B)(6) 2010. HE WAS DISCHARGED FROM HOSPITAL POSTOPERATIVELY ON (B)(6) BUT SUBSEQUENTLY DEVELOPED SHORTNESS OF BREATH ON EXERTION AND REPRESENTED TO THE HOSPITAL AND SUBSEQUENTLY WAS TRANSFERRED TO THE HOSPITAL WHERE HE WAS FOUND TO HAVE PERICARDIAL EFFUSION/TAMPONADE, ALONG WITH RV FAILURE. HIS PERICARDIAL EFFUSION WAS DRAINED WITH PERICARDIOCENTESIS AND WAS ALSO TREATED WITH DIURESIS. HE WAS ALSO FOUND TO HAVE HYPONATREMIA WITH A SODIUM LEVEL OF 123. THE HYPONATREMIA ESSENTIALLY STABILIZED WITHOUT SPECIFIC TREATMENT. GIVEN HIS PROGRESS IN THE CCU, HE WAS TRANSFERRED TO THE WARD ON (B)(6). SUBSEQUENTLY, ON (B)(6), A CODE BLUE WAS CALLED. THE PATIENT WAS FOUND ON THE BATHROOM FLOOR PULSELESS. HE WAS IN V-FIB/PEA ARREST. HE REQUIRED OVER 30 MINUTES OF ACTIVE RESUSCITATION, ALONG WITH DOPAMINE AND NOREPINEPHRINE INFUSIONS. HE WAS SENT FOR A CT HEAD AND NECK AS HE HAD FALLEN ON THE FLOOR IN THE BATHROOM. CT HEAD REVEALED NO ACUTE ABNORMALITIES. HOWEVER, THE SCAN OF HIS NECK REVEALED ANTEROLISTHESIS OF C3 ON C4. NEUROSURGERY WAS CONSULTED AND THEY RECOMMENDED CONSERVATIVE TREATMENT OF HIS NECK WITH C-COLLAR UNTIL HE WAS MORE HEMODYNAMICALLY STABLE AND COULD UNDERGO MRI FOR FURTHER ASSESSMENT. AS SUCH, ON (B)(6) HE WAS READMITTED TO THE CCU POST ARREST AND WAS COOLED AS PER PROTOCOL. ON (B)(6), HE WAS FOUND TO BE ELIGURIC WITH HYPERKAKEMIA, POTASSIUM 7.4. THE CCU TEAM DISCUSSED HIS POOR PROGNOSIS [WITH THE] FAMILY IN LIGHT OF HIS ARREST, PROLONGED RESUSCITATION, LIKELY ANOXIC BRAIN INJURY. IT WAS DECIDED BY HIS FAMILY THAT THEY DID NOT WISH TO FURTHER ESCALATE TREATMENT AND AS SUCH NO HEMODIALYSIS WAS UNDERTAKEN. HE WAS MADE DNR AT THAT POINT. WITH MEDICAL TREATMENT, HIS HYPERKALEINIA CORRECTED AND HIS LAST POTASSIUM VALUE WAS 4.5. ON (B)(6), THE CCU TEAM OBTAINED A NEUROLOGY CONSULTATION FOR PROGNOSTICATION. IT WAS FOUND THAT HE HAD A LESS THAN 1% CHANCE OF NEUROLOGIC RECOVERY WITH LIKELY VEGETATIVE STATE. THE FAMILY AGREED FOR PROVIDING HIM ONLY WITH COMFORT MEASURES AND TO WITHDRAW ALL ACTIVE CARE. AS SUCH, VASOACTJVE SUPPORT WAS DISCONTINUED AND [HE] WAS EXTUBATED TO ROOM AIR. HE RECEIVED MORPHINE ARID VERSED FOR COMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 10A024

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death