BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10537644 · Received September 15, 2020

    Report

    Report Number
    2024168-2020-07733
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    June 3, 2019
    Report Date
    September 15, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227288
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION, VENTRICULAR ARRHYTHMIAS, STENOSIS, PROLAPSE AND ANGINA ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH SILENT ISCHEMIA AND SEVERE CALCIFICATION WITHIN THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY, 75% STENOSED LESION. ATHERECTOMY WAS PERFORMED AND A 2.75X33MM (1550275-33, 8080241) AND 3.0X28MM (1550300-28, 8080941) XIENCE SIERRA STENTS WERE IMPLANTED IN THE CX WITH ACCEPTABLE RESULTS. POST-IMPLANTATION, INTRA-STENT PLAQUE PROTRUSION WAS OBSERVED WITH THE 3.0X28MM XIENCE SIERRA STENT. ADDITIONAL BALLOON DILATATION WAS PERFORMED. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN, ELEVATED TROPONIN, AND A NON-ST ELEVATED MYOCARDIAL INFLATION (NSTEMI) WAS DIAGNOSED. MEDICATION HAD BEEN TAKEN PRIOR AND A HEPARIN DRIP WAS INITIATED. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND CARDIOVERSION SHOCKS WERE PROVIDED TWO TIMES. ON (B)(6) 2020, THE PROXIMAL CX, 3.0X28MM XIENCE SIERRA STENT, WAS OBSERVED WITH 90% OCCLUSION, IN-STENT RESTENOSIS WITHIN THE PROXIMAL 5MM OF THE STENT. AS TREATMENT, ANOTHER STENT WAS IMPLANTED. THE EVENT RESOLVED. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000388 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550300-28 8080941 08717648227288

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R| S