BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE SIERRA

    MDR report key: 9721950 · Received February 18, 2020

    Report

    Report Number
    2024168-2020-01581
    Event Type
    Death
    Date Received
    February 18, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 18, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227103
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 EFFECTS OF CEREBROVASCULAR ACCIDENT, DEATH, DYSPNEA AND PULMONARY EDEMA ARE LISTED IN THE XIENCE SIERRA, EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), ELECTRONIC 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 TREATMENT APPEARS 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). ON (B)(6) 2020, THE PATIENT PRESENTED WITH ELEVATED CARDIAC ENZYMES AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 80% STENOSED LESION. A 2.5X18MM XIENCE SIERRA STENT (1550250-18, 9090341) WAS SUCCESSFULLY IMPLANTED IN THE MID LAD. REPORTEDLY, THERE WAS TIMI FLOW 3, 0% STENOSIS, AND THERE WERE NO PROCEDURAL COMPLICATIONS. THAT SAME DAY, THE PATIENT EXPERIENCED PROGRESSIVE SHORTNESS OF BREATH. BLOOD OXYGEN WAS AT 78%, ELECTROCARDIOGRAM SHOWED NORMAL SINUS RHYTHM, AND A CHEST X-RAY SHOWED FLUFFY, DIFFUSE INFILTRATES. MEDICATIONS WERE PROVIDED AS A CONCERN FOR CONGESTIVE HEART FAILURE (CHF). THE PATIENT HAD GONE INTO SEPTIC SHOCK RELATED TO PRE-EXISTING PYELONEPHRITIS/CHOLECYSTITIS. ON (B)(6) 2020, A BLOOD TRANSFUSION HAD BEEN PROVIDED. ON (B)(6) 2020, A LARGE LEFT MIDDLE CEREBRAL ARTERY (MCA) ISCHEMIC STROKE WAS OBSERVED PER IMAGING. ON (B)(6) 2020 A BUBBLE STUDY, CT OF THE HEAD, AND A 2D ECHOCARDIOGRAM WAS PERFORMED. PER IMAGING, THERE WAS NO EVIDENCE OF A CARDIAC ETIOLOGY EMBOLISM. PER NEUROLOGY, THE STROKE WAS EITHER DUE TO HYPOPERFUSION OR EMBOLIC (OF A NON-CARDIAC SOURCE PER CARDIOLOGIST). ON (B)(6) 2020, THE PATIENT EXPIRED. REPORTEDLY, THIS EVENT LED TO THE PATIENT'S DEATH. PER PHYSICIAN, THE EVENTS, INCLUDING STROKE AND PATIENT DEATH, WERE UNRELATED TO THE XIENCE SIERRA DEVICE AND UNRELATED TO THE INDEX PROCEDURE. PER PHYSICIAN, THE XIENCE SIERRA STENT REMAINED PATENT AS THERE WERE NO ELECTROCARDIOGRAM (EKG) CHANGES. THERE WAS NO DEVICE MALFUNCTION AND NO THROMBUS OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184231 XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550250-18 9090341 08717648227103

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death