BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA 70CC TAH-T

    MDR report key: 5579464 · Received April 14, 2016

    Report

    Report Number
    3003761017-2016-00155
    Event Type
    Death
    Date Received
    April 14, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    OPERATOR OF DEVICE CHANGED TO HEALTH PROFESSIONAL AFTER THE SYNCARDIA TECHNICIAN NOTED THE APPARENT TEAR IN THE RIGHT VENTRICLE, THE TAH-T L/N 072084 WAS SENT FOR EVALUATION BY A CONTRACT LABORATORY THAT HAD PREVIOUSLY CONDUCTED TAH-T DIAPHRAGM ANALYSES. THE RESULTS OF THE INVESTIGATION AND EVALUATION FROM THE CONTRACT LABORATORY CONCLUDED THAT THE ROOT CAUSE OF THE BLOOD DIAPHRAGM FAILURE WAS THINNING OF THE BLOOD DIAPHRAGM LIKELY ATTRIBUTABLE TO CONTACT ABRASION WITH THE ADJACENT INTERMEDIATE DIAPHRAGM. THERE WAS NO EVIDENCE OF DEFECT IN EITHER THE TAH-T VENTRICLE MATERIALS OR IN VENTRICLE CONSTRUCTION. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. CE (B)(4) FOLLOW-UP REPORT 1.

    Description of Event or Problem · 1

    TAH-T L/N 072084 WAS RETURNED TO SYNCARDIA AFTER EXPLANT FROM A PATIENT WHO EXPIRED AFTER 4 1/2 YEARS OF TAH-T SUPPORT. THE DETAILS OF THE PATIENT'S DEATH ARE UNKNOWN. DURING ROUTINE EXPLANT ANALYSIS AT SYNCARDIA, THE TECHNICIAN NOTED THAT THE BLOOD DIAPHRAGM OF THE RIGHT VENTRICLE (L/N 071702R0809) APPEARED TO BE TORN. TAH-T L/N 072084 HAD BEEN HANDLED ABNORMALLY FOLLOWING EXPLANT. THE CUSTOMER REPORTED THAT, RATHER THAN BEING PACKAGED IN AN APPROVED SYNCARDIA EXPLANT RETRIEVAL KIT AND SHIPPED PROMPTLY TO SYNCARDIA, TAH-T L/N 072084 WAS SENT TO ANOTHER INSTITUTION AND WAS APPARENTLY SUBJECTED TO RIGOROUS CHEMICAL TREATMENT AND HANDLING UNDER UNDETERMINED CONDITIONS. TAH-T L/N 072084 WILL UNDERGO FURTHER EVALUATION AND THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    TAH-T L/N 072084 WAS RETURNED TO SYNCARDIA AFTER EXPLANT FROM A PATIENT WHO EXPIRED AFTER 4½ YEARS OF TAH-T SUPPORT. THE DETAILS OF THE PATIENT'S DEATH ARE UNKNOWN. TAH-T L/N 072084 HAD BEEN HANDLED ABNORMALLY FOLLOWING EXPLANT. THE CUSTOMER REPORTED THAT, RATHER THAN BEING PACKAGED IN AN APPROVED SYNCARDIA EXPLANT RETRIEVAL KIT AND SHIPPED PROMPTLY TO SYNCARDIA, TAH-T L/N 072084 WAS SENT TO ANOTHER INSTITUTION AND WAS APPARENTLY SUBJECTED TO RIGOROUS CHEMICAL TREATMENT AND HANDLING UNDER UNDETERMINED CONDITIONS. IT WAS ONLY AFTER SUCH IMPROPER HANDLING THAT SYNCARDIA RECEIVED AND WAS ABLE TO ANALYZE TAH-T L/N 072084. DURING THE ANALYSIS AT SYNCARDIA, THE TECHNICIAN NOTED THAT THE BLOOD DIAPHRAGM OF THE RIGHT VENTRICLE (L/N 071702R0809) APPEARED TO BE TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231480 SYNCARDIA 70CC TAH-T BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 072084

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death