BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10454673 · Received August 26, 2020

    Report

    Report Number
    2024168-2020-07117
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    June 26, 2020
    Report Date
    August 26, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227141
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 ANGINA AND STENOSIS 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL XIENCE SIERRA DEVICE REFERENCED FILED UNDER 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 RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION AND A 70% STENOSED LESION WITHIN THE MID RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED WITHIN THE MID RCA AND A 2.5X38MM (1550250-38, 9020841) AND A 2.75X23MM (1550275-23, 8091141) XIENCE SIERRA STENT WERE IMPLANTED. POST-DILATATION WAS PERFORMED. 0% RESIDUAL STENOSIS WAS NOTED WITHOUT A DEVICE ISSUE REPORTED. ON (B)(6) 2020, DURING A FOLLOW-UP, THE PATIENT REPORTED EXPERIENCING ONGOING, INTERMITTENT CHEST PAIN THAT WAS RELIEVED WITH REST. AS TREATMENT, THE PATIENT'S MEDICATION (NITROGLYCERINE) WAS PROVIDED/ADJUSTED. ON (B)(6) 2020, DURING A FOLLOW-UP, THE PATIENT PRESENTED WITH WORSENING CHEST PAIN. PER NUCLEAR STRESS TEST, ST SEGMENT DEPRESSION WAS OBSERVED. ON (B)(6) 2020, THE PATIENT CONTINUED TO HAVE CHEST PAIN. THE PATIENT WAS HOSPITALIZED AND IN-STENT RESTENOSIS WAS OBSERVED IN BOTH RCA, XIENCE SIERRA STENTS. AS TREATMENT, ANGIOPLASTY WAS PERFORMED ON THE 99% OCCLUDED LESION WITHIN THE RCA. THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921240 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550250-38 9020841 08717648227141

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R XIENCE SIERRA STENT