BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 11716780 · Received April 23, 2021

    Report

    Report Number
    2024168-2021-03449
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 23, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227158
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT: THE PATIENTS DEMOGRAPHICS WERE OBTAINED FROM INDEX PROCEDURE DATA ON (B)(6) 2019. 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 EFFECTS OF ANGINA AND STENOSIS ARE LISTED IN THE XIENCE SIERRA, EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH A SEVERELY CALCIFIED, PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY WITH A CHRONIC TOTAL OCCLUSION AND 70% STENOSED LESION. PRE-DILATATION WAS PERFORMED AND A 2.75X8MM XIENCE SIERRA STENT (1550275-08, 8092641) WAS IMPLANTED IN THE PROXIMAL CX, WITHOUT A DEVICE ISSUE REPORTED. FOLLOWING, PRE-DILATATION WAS PERFORMED ON THE 2ND OBTUSE MARGINAL (OM) CORONARY ARTERY, 95% STENOSED LESION AND A 2.75X8MM XIENCE SIERRA STENT (1550250-08, 9020541) WAS IMPLANTED WITHOUT A DEVICE ISSUE REPORTED. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN. PER IMAGING, THE PROXIMAL CX WAS 90% STENOSED. AS TREATMENT, ANOTHER DRUG-ELUTING STENT WAS PLACED IN THE PROXIMAL CX. IN ADDITION, ANOTHER STENT WAS ALSO IMPLANTED IN THE 80% STENOSED PROXIMAL RIGHT CORONARY ARTERY LESION. PER PHYSICIAN, THERE WAS NO DEVICE MALFUNCTION AND THE EVENT WAS UNRELATED TO THE XIENCE DEVICE. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610064 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550275-08 8092641 08717648227158

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R XIENCE SIERRA STENT