BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2980761 · Received February 27, 2013

    Report

    Report Number
    2015691-2013-19403
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS NOT EXPLANTED AFTER THE PATIENT'S EXPIRATION. IN ADDITION, A DESIGN HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED/PERFORMED AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE, CARDIAC ARREST IS A POTENTIAL RISK ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. THE IMMEDIATE CAUSE OF SUDDEN CARDIAC ARREST IS USUALLY AN ABNORMAL HEART RHYTHM (ARRHYTHMIA). SOME OTHER HEART CONDITIONS THAT CAN LEAD TO SUDDEN CARDIAC ARREST INCLUDE CAD, MI, CARDIOMYOPATHY, VALVULAR HEART DISEASE, AND CONGENITAL HEART DISEASE. FACTORS THAT INCREASE A PATIENT'S RISK OF CARDIAC ARREST INCLUDE SMOKING, ADVANCED AGE, GENDER, HTN, LOW BLOOD PRESSURE, OBESITY, DIABETES, A SEDENTARY LIFESTYLE, A HISTORY OF ARRHYTHMIA, AND NUTRITIONAL IMBALANCES. IN THIS CASE, THE CAUSE OF THE CARDIAC ARREST CANNOT BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT IN ADDITION TO THE PROCEDURE ITSELF, THE PATIENT EXPERIENCED ACIDOSIS AND ACUTE RENAL FAILURE POST TAVR AND THIS ALONG WITH THE PATIENT'S ADVANCED AGE AND CO-MORBIDITIES MAY HAVE CONTRIBUTED TO THE EVENT. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, FIVE DAYS POST TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE PATIENT EXPIRED. ADDITIONAL INFORMATION PROVIDED INDICATED THE ATTENDING PHYSICIAN BELIEVES THAT THE PATIENT'S DEATH WAS NOT DEVICE RELATED. THE PATIENT HAD BEEN ACIDOTIC A FEW DAYS POST PROCEDURE, AND SHOWED SIGNS OF ACUTE RENAL FAILURE. ON (B)(6) 2013, THE PATIENT HAD A PEA ARREST AND ACLS PROTOCOL WITH CPR WAS INITIATED. AFTER 3 MINUTES, CPR WAS STOPPED AS THE PATIENT WAS BROUGHT BACK. IT WAS NOTED THE PATIENT HAD DEVELOPED A BRADYCARDIC RHYTHM AND WAS HYPOTENSIVE. GIVEN THE SEVERITY OF HER ILLNESS, HER FAMILY ELECTED TO WITHDRAW CARE. ON (B)(6) 2013, THE PATIENT CODED AGAIN AND DIED. THE OFFICIAL CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84910 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A 59372461

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death