BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10359454 · Received August 3, 2020

    Report

    Report Number
    2024168-2020-06449
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    May 15, 2019
    Report Date
    August 3, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 INTIMAL DISSECTION, THROMBOSIS AND PROLAPSE ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), 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 ADDITIONAL XIENCE SIERRA STENT MENTIONED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH A MID-LEFT ANTERIOR DESCENDING (LAD) 90% STENOSED LESION, AND A MID-RIGHT CORONARY ARTERY (RCA) 70% STENOSED LESION. FOLLOWING PRE-DILATATION, A 2.5X38MM XIENCE SIERRA STENT (1500250-38, 9030141) WAS IMPLANTED IN THE MID LAD. POST-STENT PLACEMENT, AN INTRA-STENT PLAQUE, THROMBUS, AND AN EDGE DISSECTION WAS OBSERVED. ADDITIONAL POST-DILATATION PERFORMED. THE END RESULT WAS 0% RESIDUAL STENOSIS WITH TIMI FLOW III. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION. A 3.5X23MM XIENCE SIERRA STENT (1500350-23, 9030441) WAS IMPLANTED IN THE MID RCA. POST STENT IMPLANTATION, AN INTRA-STENT PLAQUE PROTRUSION AND AN EDGE DISSECTION WERE OBSERVED. ADDITIONAL POST-DILATATION WAS PERFORMED AND A 3.5X8MM XIENCE SIERRA STENT (1500350-08, 8112041) STENT WAS IMPLANTED. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION THE END RESULTS WERE 0% RESIDUAL STENOSIS WITH TIMI FLOW III. THAT SAME DAY POST-PROCEDURE, ELEVATED CARDIAC ENZYMES WERE OBSERVED AND SIGNIFICANTLY ELEVATED ENZYMES WERE OBSERVED (B)(6) 2019. REPORTEDLY, THE ELEVATION WAS NOT SERIOUS, THERE WAS NO ASSOCIATED SERIOUS INJURY, THERE WAS NO DEVICE MALFUNCTION, AND NO TREATMENT PROVIDED. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820459 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9030141

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention