BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA

    MDR report key: 9496541 · Received December 19, 2019

    Report

    Report Number
    2024168-2019-14752
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    December 14, 2018
    Report Date
    December 19, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227417
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2019001. 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 EFFECT(S) OF ANGINA, STENOSIS, AND PROLAPSE ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) 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 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.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD), SEVERE IN-STENT RESTENOSIS. PRE-DILATATION WAS PERFORMED AND A 3.0X23MM (1550300-23, 8091041) XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LAD. FOLLOWING, A PLAQUE SHIFT OCCURRED INTO THE DIAGONAL CORONARY ARTERY, TREATED WITH BALLOON ANGIOPLASTY. THERE WERE NO FURTHER COMPLICATIONS REPORTED. A 3.5X15MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD. REPORTEDLY, BOTH STENTS WERE IMPLANTED WITH ACCEPTABLE RESULTS, TIMI FLOW III AND 0% DIAMETER STENOSIS. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED FOR WORSENING CHEST PAIN WITH ACTIVITY. PER IMAGING, THE MID LAD WAS SEVERELY RESTENOSED AND CORONARY ARTERY DISEASE WAS NOTED IN THE FIRST DIAGONAL. REPORTEDLY, THE PROXIMAL LAD, 3.5X15MM XIENCE SIERRA STENT REMAINED PATENT. AS TREATMENT, ANOTHER PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE MID LAD AND DIAGONAL CORONARY ARTERIES, PLACING ADDITIONAL STENTS. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288775 XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 8091041 08717648227417

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R