BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6201402 · Received December 22, 2016

    Report

    Report Number
    2024168-2016-09212
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 22, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648123566
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF PERFORATION, MYOCARDIAL INFARCTION, AND DEATH ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED, MILDLY TORTUOUS, AND DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A 2.0X15MM NON-ABBOTT BALLOON A 2.75X28MM XIENCE PRIME STENT WAS DEPLOYED AT THE LESION SITE. POST-DILATATION WAS PERFORMED WITH A 3.0X12MM NC NON-ABBOTT BALLOON AND THE PROCEDURE WAS SUCCESSFUL WITHOUT RESIDUAL STENOSIS. MINUTES AFTER THE PROCEDURE THE PATIENT HAD A MYOCARDIAL RUPTURE AND MYOCARDIAL INFARCTION. PERICARDIAL ASPIRATION WAS PERFORMED; HOWEVER, SUBSTANTIAL AMOUNT OF BLOOD WAS ASPIRATED FROM THE PERICARDIUM AND THE PATIENT CONDITION WORSENED BEFORE ANY FURTHER TREATMENT COULD HAVE BEEN GIVEN. THE PATIENT PASSED AWAY. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847718 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5121741 08717648123566

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death