BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 11687908 · Received April 19, 2021

    Report

    Report Number
    2024168-2021-03264
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    July 18, 2020
    Report Date
    June 1, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 STENOSIS IS LISTED IN THE XIENCE PRO A 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(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.NA.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE LEFT ANTERIOR DESCENDING (LAD), 70% STENOSED LESION AND A 3.5X33MM XIENCE PROA STENT (1128350-33, 8010841) WAS IMPLANTED WITH ACCEPTABLE RESULTS. THERE WAS 0% RESIDUAL STENOSIS AND NO COMPLICATION. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED, AND IN-STENT RESTENOSIS WAS OBSERVED IN THE FIRST DIAGONAL CORONARY ARTERY, WITHIN THE 3.5X33MM XIENCE LAD STENT. ON (B)(6) 2020, ANOTHER PCI REVASCULARIZATION WAS PERFORMED IN THE FIRST DIAGONAL, 90% OCCLUDED FIRST DIAGONAL CORONARY ARTERY. REPORTEDLY, THIS INCLUDED THE LAD TARGET LESION, 3.5X33MM XIENCE PROA STENT. THERE WAS NO DEVICE MALFUNCTION. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583183 XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 8010841

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R