BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3962061 · Received July 28, 2014

    Report

    Report Number
    2134265-2014-04346
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2014-04345. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A QUITE CALCIFIED AND TORTUOUS LEFT MAIN (LM) ARTERY EXTENDING TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN UNSPECIFIED SIZE PROMUS PREMIER¿ DRUG ELUTING STENT WAS INITIALLY DEPLOYED IN THE LM ARTERY. ANOTHER UNSPECIFIED SIZE PROMUS PREMIER¿ DRUG ELUTING STENT WAS THEN SELECTED FOR USE AND ADVANCED TO TREAT THE LAD LESION. HOWEVER, IT WAS NOTICED THAT THE STENT DELIVERY SYSTEM (SDS) WOULD NOT ADVANCE NOR WOULD IT RETRACT. THE PHYSICIAN HAD TO PULL THE DEVICE AND THE UNDEPLOYED STENT DISLODGED. THE PHYSICIAN RETRIEVED THE DISLODGED STENT USING A NON-BSC BALLOON CATHETER BUT IN THE PROCESS, CRUMPLED THE IMPLANTED STENT IN THE LM ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437836 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1