BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4190412 · Received October 21, 2014

    Report

    Report Number
    2134265-2014-06305
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    June 15, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE 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 ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURED. IN (B)(6) 2014, THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND A 2.50X12MM PROMUS PREMIER¿ STENT WAS IMPLANTED IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IN (B)(6) 2014, THE PATIENT WAS PRESENTED WITH A THREE DAY HISTORY OF CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH AND MILD DYSPNEA. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND PATIENT WAS HOSPITALIZED ON THE SAME DAY. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN AND PRASUGREL. THE STUDY DRUG WAS LAST TAKEN IN (B)(6) 2012. ON THE FOLLOWING DAY, CORONARY ANGIOGRAPHY REVEALED A 70-80% ISR AT THE PROXIMAL EDGE OF THE 2.50 X 12 MM PROMUS PREMIER¿ STENT IN MID LAD. THE LESION WAS THEN TREATED WITH PLACEMENT OF A 2.50 X 9 MM NON-BSC DRUG ELUTING STENT. FOLLOWING POST DILATATION, RESIDUAL WAS 0%. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667506 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R