BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3962627 · Received July 29, 2014

    Report

    Report Number
    9612164-2014-01005
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    January 4, 2011
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (INSUFFICIENT INFORMATION). INHERENT RISK OF PROCEDURE (STENT MIGRATION IS LISTED IN THE ENDEAVOR SPRINT INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT OF A PCI PROCEDURE). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. DEVICE NOT RETURNED. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE (STENT MIGRATION IS LISTED IN THE ENDEAVOR SPRINT INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT OF A PCI PROCEDURE). UNABLE TO CONFIRM COMPLAINT. (INSUFFICIENT INFORMATION). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN IMPLANTED TWO ENDEAVOR SPRINT DRUG ELUTING STENTS IN THE RIGHT POSTERIOR ATRIOVENTRICULAR SEGMENT AND WHICH HAD 25% STENOSIS, DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT THE 2ND ENDEAVOR SPRINT STENT THAT WAS IMPLANTED, MIGRATED FROM ITS ORIGINAL POSITION. IT WAS REPORTED AS 'STENT MIGRATION TO SIDE BRANCH NOT COVERING THE OSTIUM'. THE PATIENT WAS TREATED WITH A KISSING BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440775 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001031884

    Patients

    Seq Age Sex Outcome Treatment
    1