BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4250561 · Received November 14, 2014

    Report

    Report Number
    2134265-2014-07089
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. IN (B)(6) 2014, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. THE TARGET LESION WAS A CONCENTRIC, OSTIAL, TYPE B1, DE NOVO, NON DIFFUSE LESION LOCATED IN THE NON CALCIFIED AND NON TORTUOUS FIRST OBTUSE MARGINAL (OM) BRANCH WITH 99% STENOSIS CONTAINED IN LESS THAN 45 DEGREE BEND AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. IT WAS TREATED WITH PREDILATATION AND PLACEMENT OF THE 2.25X20MM PROMUS PREMIER¿ DRUG ELUTING STENT AT 8 ATMOSPHERES. POST DEPLOYMENT OF THE STUDY STENT, VESSEL PERFORATION WAS NOTED AT THE DISTAL END OF FIRST OM. HENCE, POST DILATATION WAS PERFORMED WITH A 2.0 MM UNSPECIFIED BALLOON CATHETER AT 1 ATMOSPHERES FOR 6 MINUTES, RESIDUAL STENOSIS WAS VISUALLY CONFIRMED AS 0% AND TIMI 3 FLOW WAS RESTORED. IN ADDITION, MEDICATION WAS ALSO GIVEN TO TREAT THE EVENT. THE PHYSICIAN SUSPECTED THAT THE CAUSE OF THE PERFORATION WAS DUE TO AN UNSPECIFIED GUIDEWIRE. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738667 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925120220

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention