BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3790462 · Received May 5, 2014

    Report

    Report Number
    2134265-2014-02344
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED FOR ANALYSIS WAS THE DELIVERY DEVICE AND TWO DETACHED STENTS THAT WERE ENTANGLED WITH EACH OTHER. AN EXAMINATION OF THE DETACHED STENTS FOUND THAT THE STENTS WERE SEVERELY STRETCHED AND DAMAGED. A CLOSER EXAMINATION IDENTIFIED THAT SOME STRUTS WERE FRACTURED HOWEVER, DUE TO THE SEVERE STRETCHING AND DAMAGE THAT WAS EVIDENT, IT WAS NOT POSSIBLE TO DETERMINE WHICH SIZE STENT EXHIBITED THE STRUT FRACTURES. AN EXAMINATION OF THE BALLOON IDENTIFIED A CLEAR IMPRESSION OF THE STENT CRIMP ON THE BALLOON MATERIAL. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF CAUSED BY OTHER HAS BEEN ASSIGNED TO THIS EVENT AS THE COMPLAINT INDICATES ANOTHER DEVICE/DRUG/SUBSEQUENT PROCEDURE CAUSED THE COMPLAINT. THE COMPLAINT REPORT STATED THAT THE STENT DETACHED AFTER IT CAUGHT ON ANOTHER PROMUS PREMIER STENT DURING THE PHYSICIAN'S ATTEMPTS TO WITHDRAW ANOTHER PROMUS PREMIER DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-02343. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE THAT THE STENTS DISLODGED INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED RIGHT CORONARY ARTERY. A 3.5X38MM STENT WAS PLACED DISTALLY. THE PROXIMAL PORTION OF THE VESSEL WAS DILATED WITH MULTIPLE BALLOONS INCLUDING A CUTTING BALLOON. A 4.0X12MM PROMUS PREMIER MR DEVICE WAS SELECTED AND ADVANCED, BUT IT WAS NOT LONG ENOUGH FOR THE LESION AND WAS REMOVED. A 4.0X16MM PROMUS PREMIER MR WAS INTRODUCED WITH DIFFICULTY THROUGH THE TOUHY AND WAS REMOVED. WHEN THE 4.0X16MM STENT WAS REMOVED IT ALSO CAUGHT THE PRIOR 4.0X12MM STENT WHICH WAS ALSO IN THE TOUHY. A NEW TOUHY WAS ATTACHED AND ANOTHER 4.0X16MM PROMUS PREMIER MR WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS FINE.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS USER FACILITY MEDWATCH: MW5035621.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267945 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952812400 0016749055

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CO-PILOT TOUHY