BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2924106 · Received January 22, 2013

    Report

    Report Number
    2015691-2013-19151
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 24, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE SAPIEN VALVE WAS PERFORMED AND ALL MANUFACTURERS' SPECIFICATIONS WERE MET PRIOR TO RELEASE FOR DISTRIBUTION. PER THE IFU, ENDOCARDITIS IS A KNOWN COMPLICATION ASSOCIATED WITH HEART VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. ENDOCARDITIS IS AN INFECTION OF A NATIVE OR PROSTHETIC VALVE AND MAY OCCUR EARLY OR LATE AFTER VALVE REPLACEMENT. THE INFECTION TYPICALLY RESULTS FROM EITHER SEEDING OF THE VALVE WITH BACTERIA AT THE TIME OF SURGERY BY THE OPERATIVE TEAM, OR AT A LATER TIME BY AN INFECTION ELSEWHERE IN THE BODY. IN THIS CASE, WHILE THE AORTIC VALVE ENDOCARDITIS WAS DIAGNOSED TWENTY THREE MONTHS POST VALVE REPLACEMENT, THE PATIENT HAD A HISTORY OF A NON-HEALING CHEST WOUND INFECTION POST TAVR AND (B)(6) INFECTION. 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 EDWARDS THV PATIENT SCREENING 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.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE (B)(4) STUDY, APPROXIMATELY TWO YEARS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR MULTIPLE INFECTIONS INCLUDING ENDOCARDITIS. PER MEDICAL RECORDS RECEIVED, THE PATIENT IS AN (B)(6) FEMALE WITH A HISTORY OF AORTIC STENOSIS, CORONARY ARTERY DISEASE, S/P AORTIC VALVE REPLACEMENT 2011, HISTORY OF ONGOING WOUND INFECTION WITH (B)(6) INFECTION POST SURGERY, S/P CORONARY STENT PLACEMENT, S/P ABDOMINAL AORTIC ANEURYSM REPAIR IN 2000, S/P CABG, DEMENTIA AND ALZHEIMER'S. SHE WAS BROUGHT TO THE EMERGENCY ROOM BECAUSE OF GENERALIZED WEAKNESS AND MENTAL STATUS CHANGES AND FEVER. IN THE EMERGENCY ROOM, THE PATIENT WAS FOUND TO HAVE A SEPSIS FROM A URINARY TRACT INFECTION. APPARENTLY, SHE HAD BEEN SICK FOR THE LAST FEW DAYS AND GRADUALLY GOTTEN WORSE TO THE POINT THAT SHE WAS NOT VERY RESPONSIVE IN THE EMERGENCY ROOM. THE PATIENT'S INFECTIONS ALSO INCLUDED ENDOCARDITIS, BACTEREMIA WITH (B)(6) CULTURES (B)(6) FOR (B)(6). THE PATIENT WAS TREATED WITH IV ANTIBIOTICS INCLUDING FLAGYL FOR C. DIFF COLITIS AND IMPROVED SLOWLY. HER LONG-TERM PROGNOSIS WAS POOR DUE TO HER AGE, DEBILITY, AND A NON-HEALING WOUND IN HER CHEST. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. TRANSTHORACIC ECHOCARDIOGRAM (TTE) RESULTS DURING HOSPITALIZATION REPORTED FINDINGS THAT WERE CONSISTENT WITH A NORMAL AORTIC PROSTHESIS WITH A PEAK GRADIENT OF 21MMHG AND A MEAN GRADIENT OF 13MMHG. IT WAS NOTED THAT THE AORTIC VALVE WAS NOT WELL SEEN AND THEREFORE, COULD NOT EXCLUDE VEGETATIONS ON THE PROSTHETIC VALVE. THERE WAS NO OBVIOUS EVIDENCE FOR ENDOCARDITIS ON THIS 20 SURFACE ECHO. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) RESULTS NOTED IT WAS POSITIVE FOR A SMALL VEGETATION OF THE RIGHT MITRAL VALVE CUSP. CHEST X-RAY RESULTS DURING HOSPITALIZATION: COMPARED TO PREVIOUS STUDY, PA AND LATERAL VIEWS OF THE CHEST DEMONSTRATED INTERVAL INCREASE IN HEART SIZE. THORACOTOMY CHANGES AND PROSTHETIC AORTIC VALVE WERE NOTED. PULMONARY VASCULATURE IS MILDLY CONGESTED. MILD CENTRAL PARA-BRONCHIAL VASCULAR INTERSTITIAL EDEMA IS PRESENT. NO CONSOLIDATED PNEUMONIA, PATHOLOGIC ADENOPATHY OR PLEURAL EFFUSION IS IDENTIFIED. THE FINAL IMPRESSION WAS CONGESTIVE HEART FAILURE ASSOCIATED WITH AORTIC VALVE PROSTHESIS AND THORACOTOMY CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31147 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention