BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8287087 · Received January 29, 2019

    Report

    Report Number
    2024168-2019-00650
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    January 4, 2019
    Report Date
    March 8, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). PART NUMBER WAS CHANGED FROM 1550250-23 TO 1550275-23, LOT NUMBER 8081141 TO 8091141. 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 PERFORATION IS LISTED IN THE XIENCE SIERRA, EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), ELECTRONIC INSTRUCTIONS FOR USE (IFU) 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 OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE GRAFTMASTER DEVICE IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID TO PROXIMAL LEFT ANTERIOR CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND MODERATELY STENOSED. A ROTATIONAL ATHERECTOMY SYSTEM WAS FIRST USED AND THEN TWO XIENCE SIERRA STENTS WERE PLACED. THEN, THE NC TREK RX 3.50 X 12 MM BALLOON DILATATION CATHETER WAS USED FOR POST-DILATATION OF TWO XIENCE SIERRA STENTS WHEN IT WAS NOTICED THAT THERE WAS A PERFORATION AT THE PROXIMAL 2.5 X 23 MM XIENCE SIERRA STENT. AN IMPELLA BLOOD PUMP WAS INSERTED AS SUPPORT DUE TO THE PERFORATION. THEN, A GRAFTMASTER 2.8 X 19 MM WAS ADVANCED BUT FAILED TO CROSS THE ANATOMY. A 3.5 X 19 MM GRAFTMASTER COVERED STENT WAS THEN DEPLOYED TO SUCCESSFULLY SEAL THE PERFORATION. THE PATIENT WAS GIVEN DRUGS AND SENT TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. THE USE OF THE GRAFTMASTERS DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS, NOR DID THE EXACERBATE THE EXISTING PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77541 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8091141

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R STENT: XIENCE SIERRA 2.5 X 38 MM