BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8561593 · Received April 29, 2019

    Report

    Report Number
    2024168-2019-03380
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    February 23, 2019
    Report Date
    April 29, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648227004
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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 EFFECT OF DISSECTION IS LISTED IN THE XIENCE SIERRA, EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE, AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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. THE 2.25X18MM (8120341) AND 2.5X28MM XIENCE SIERRA (8102441) STENTS REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION, THROMBUS AND CARDIAC ARREST. A 2.25 X 18 MM XIENCE SIERRA STENT (8120341) AND A 2.5 X 28 MM XIENCE SIERRA STENT (8102441) WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. SLUGGISH FLOW WAS NOTED AFTER STENT DEPLOYMENT; HOWEVER, NO ADDITIONAL INTERVENTION WAS PERFORMED. ON (B)(6) 2019, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND WAS TAKEN BACK TO THE CATH LAB. CORONARY ANGIOGRAPHY NOTED THROMBUS IN THE STENTED SEGMENT. A 2.5 X 33 MM XIENCE SIERRA STENT AND A 2.25 X 12 MM XIENCE SIERRA STENT (8090341) WERE IMPLANTED TO TREAT THE THROMBUS. POST DILATATION WAS PERFORMED USING AN UNSPECIFIED NC DILATATION CATHETER. A NON-FLOW LIMITING EDGE DISSECTION WAS NOTED AT THE 2.25 X 12 MM XIENCE SIERRA STENT. NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE DISSECTION. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355569 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8090341 08717648227004

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other STENT: XIENCE SIERRA 2.25X18, 2.5X28