BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10049480 · Received May 12, 2020

    Report

    Report Number
    2024168-2020-04257
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    April 16, 2020
    Report Date
    June 15, 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 · 0

    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 OF PROLAPSE 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL XIENCE SIERRA DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE MID RIGHT CORONARY ARTERY (RCA), 70% STENOSED LESION. A 3.5X23MM (1500350-23, 9110141) XIENCE SIERRA STENT WAS IMPLANTED DISTALLY IN THE MID RCA AND A 3.5X18MM (1500350-18, 0012041) XIENCE SIERRA STENT WAS IMPLANTED MORE PROXIMAL IN THE MID RCA. POST-IMPLANTATION, DISTAL PLAQUE SHIFT OCCURRED WITHIN THE DISTAL, 3.5X23MM XIENCE SIERRA STENT, ALONG WITH A NON-SIGNIFICANT PROXIMAL DISSECTION WITH THE 3.5X18MM XIENCE SIERRA STENT. THE 3.5X18MM XIENCE SIERRA WAS ALSO OBSERVED WITH PROXIMAL STENT MALAPPOSITION. BASED ON THE POST-STENT FINDINGS, BALLOON ANGIOPLASTY AND ANOTHER STENT, A 3.5X12MM (1500350-12, 0011341) XIENCE SIERRA STENT WAS IMPLANTED WITHOUT AN ISSUE REPORTED. REPORTEDLY, THE DISSECTION REQUIRED NO TREATMENT. THE EVENT RESOLVED WITHOUT SEQUELA. TIMI FLOW 3 WITH 0% DIAMETER STENOSIS WAS OBSERVED AND THE PROCEDURE RESULTS WERE DEEMED ACCEPTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510970 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9110141

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention XIENCE SIERRA STENT