BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 1913286 · Received December 2, 2010

    Report

    Report Number
    2015691-2010-14477
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    May 31, 2010
    Report Date
    November 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA FAX, A COPY OF THE PATIENT'S DISCHARGE SUMMARY WAS RECEIVED. THE PT. WENT IN FOR MVR ON (B)(6) 2010 AND WAS TRANSFERRED TO C-PACU FOR ADDITIONAL CARE IN CRITICAL BUT SEEMINGLY STABLE CONDITION. FOLLOWING THE NEXT FEW DAYS AFTER THE SURGERY, THE PT. HAD NOT YET RETURNED TO HER NEUROLOGIC BASELINE. SHE DID NOT APPEAR TO BE FOLLOWING ANY COMMANDS, AND IT WAS DIFFICULT TO DETERMINE IF THIS WAS A NEUROLOGIC DEFICIT. SHE CONTINUED TO BE NON-VERBAL; SHE WAS JUST GRUNTING AND NOT REALLY RESPONDING TO PAINFUL STIMULI OR VERBAL COMMANDS. CAT SCAN WAS INCONCLUSIVE, PER THE NEUROLOGIST, AND HER NEURO STATUS HAD NOT IMPROVED WHATSOEVER. ON POSTOPERATIVE DAY #5, SHE UNDERWENT AN EFG, AS THERE WAS A QUESTION BY THE NEUROLOGISTS AS TO WHETHER SHE WAS HAVING SEIZURES. HER NEUROLOGIC EXAM WAS SLIGHTLY IMPROVED IN THAT SHE STARTED TO OPEN HER EYES IN RESPONSE TO HER NAME BEING CALLED. HOWEVER, SHE STILL DID NOT FOLLOW COMMANDS. OVER THE NEXT FEW DAYS, HER HOSPITAL COURSE CAN BE SUMMARIZED AS FAILURE TO RETURN TO HER NEUROLOGIC BASELINE DESPITE NO OBVIOUS EVIDENCE OF CVA. SHE ALSO HAD IMPROVED CARDIAC PERFORMANCE OVER THE NEXT FEW DAYS AND A WAXING AND WANING NEURO EXAM WHERE SHE MOVED HER HEAD TO VERBAL STIMULI BUT DOES NOT REALLY FOLLOW COMMANDS. SHE HAD A VIDEO EEG FOR 72 HOURS AND NEUROLOGY NOTED SOME ACTIVITY IN THE LEFT TEMPORAL REGION AND THEY ALSO NOTED THAT IT APPEARED TO BE IMPROVING. SHE HAD A VERY STRONG COUGH AND WAS STABLE FROM A PULMONARY STANDPOINT. SHE OPENED HER EYES AND RESPONDED TO NOXIOUS STIMULI, BUT SHE DID NOT RESPOND IN ANY MEANINGFUL WAY. ON POSTOPERATIVE DAY #11, SHE APPEARED TO BE MUCH MORE AWAKE AND ALERT THAN SHE HAD ON ANY PREVIOUS MORNING. SHE WAS RESPONSIVE TO QUESTIONS REGARDING PAIN AND SHE FOLLOWED ALL COMMANDS, LIFTING HANDS OFF THE BED AND WIGGLING HER TOES ON REQUEST. SHE DID HAVE PERIODS OF SOMNOLENCE THAT ALTERNATED WITH PERIODS OF WAKEFULNESS, WHICH MAY HAVE BEEN RELATED TO TEMPORAL LOVE SEIZURE. SHE WAS STABLE FROM A CARDIOPULMONARY STANDPOINT AND WAS ON A DAILY REGIMEN OF LASIX. UNFORTUNATELY ON THE EVENING OF POSTOPERATIVE DAY #13, SHE HAD WITNESSED RESPIRATORY ARREST THAT STARTED WITH AGONAL BREATHING WHILE EATING DINNER. SHE WAS BAGGED AND HER HEART RATE PLUMMETED SHORTLY THEREAFTER. AS A RESULT, CODE BLUE WAS CALLED. HER HEART RATE STABILIZED AFTER SHE WAS EMERGENTLY INTUBATED AND CPR WAS DONE FOR A BRIEF PERIOD OF TIME. HER CHEST WAS OPENED AT THE BEDSIDE AND A MODERATE CLOT WAS FOUND IN THE PERICARDIUM WHICH WAS EVACUATED. SHE RECEIVED OPEN CHEST COMPRESSIONS AND INTRACARDIAC EPI AND DEFIBRILLATION. SHE WAS TAKEN EMERGENTLY TO THE OR FOR A WASHOUT. HER POSTOP DIAGNOSES AT THAT POINT WAS CARDIAC ARREST AND ARTERIOVENOUS GROOVE TEAR. SHE WAS SUBSEQUENTLY TRANSFERRED O THE C-PACU IN CRITICAL CONDITION. HER PRELIMINARY ECHO REPORT REVEALED AN EF A 55% AND WHAT APPEARED TO BE A LARGE MASS WITHIN THE RIGHT ATRIUM. THIS ECHO WAS RESULTED PRIOR TO HER RESPIRATORY AND CARDIAC ARREST. AFTER THE PATIENT RETURNED FROM THE OPERATING ROOM, SHE REMAINED HYPOTENSIVE WITH POOR CARDIAC PERFORMANCE DESPITE FLUID RESUSCITATION, BLOOD PRODUCTS, INOTROPES, AND PRESSORS. SHE HAD INCREASED CHEST TUBE DRAINAGE AND WAS GIVEN MULTIPLE ROUNDS OF PRODUCTS AND MAXED ON MOST OF HER PRESSORS. SHE WAS GIVEN BICARBONATE AND REMAINED HYPOTENSIVE WITH EXTENSIVE CHEST TUBE DRAINAGE. UNFORTUNATELY, SHE DID NOT RESPONSE FROM A HEMODYNAMIC PERSPECTIVE AND HER BLOOD PRESSURE DROPPED AND HER OXYGENATION ALSO DROPPED. HER CHEST TUBES WERE ALSO SUCTIONED FOR CLOTS. ULTIMATELY, THE PATIENT BECAME ASYSTOLIC WITH NO PULSE, PUPILS FIXED AND DILATED, AND PASSED AWAY ON (B)(6) 2010 AT 00:23.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT AND/OR DEVICE STATUS IS REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION WERE NOT PROVIDED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE REPORTED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX R-09M2914

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death