BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE SIERRA

    MDR report key: 8805180 · Received July 18, 2019

    Report

    Report Number
    2024168-2019-10162
    Event Type
    Death
    Date Received
    July 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 THROMBOSIS, HYPOTENSION, MYOCARDIAL INFARCTION AND DEATH ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. UDI NUMBER COULD NOT BE PROVIDED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED. EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD.

    Additional Manufacturer Narrative · 0

    THE STENT REMAINS IN PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER ADDITIONAL 2 UNKNOWN XIENCE SIERRA REFERENCED IN B5 AND D11 ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD.NA

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, A MODERATELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY AND A MODERATELY TORTUOUS AND MILDLY CALCIFIED FIRST OBTUSE MARGINAL ARTERY. ON (B)(6) 2019, THE PATIENT PRESENTED WITH SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND THREE UNSPECIFIED XIENCE SIERRA STENTS WERE IMPLANTED IN THE LESIONS WITHOUT ANY ISSUES. PLAVIX WAS THEN ADMINISTERED TO THE PATIENT AND THEY WERE DISCHARGED. HOWEVER, THE PATIENT DID NOT CONTINUE TAKING MEDICATION AFTER BEING DISCHARGED FROM THE HOSPITAL. THEY WERE THEN RE-HOSPITALIZED ON (B)(6) 2019 AS THEY PRESENTED WITH STEMI AND ANGIOGRAPHY REVEALED IN-STENT THROMBOSIS IN ALL THREE STENTS. THEREFORE, THE PATIENT WAS INTUBATED AND AN ASPIRATION CATHETER WAS USED. ADDITIONALLY, BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE THROMBOSIS. THE BLOOD PRESSURE WAS SIGNIFICANTLY LOW AND AN IMPELLA DEVICE WAS USED AS THE HEART WAS VERY WEAK. THE PATIENT WAS THEN TRANSFERRED TO THE CORONARY CARE UNIT (CCU) WHILE REMAINING INTUBATED. THE PATIENT DECLINED AND THEN EXPIRED DAYS LATER ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596247 XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| R| S 2 UNKNOWN XIENCE SIERRA STENTS