BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2944942 · Received February 6, 2013

    Report

    Report Number
    2134265-2013-00670
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL EXAMINATION NOTED THAT THE STENT DELIVERY SYSTEM WAS ONLY RETURNED FOR ANALYSIS, THE STENT WAS NOT RETURNED. MICROSCOPIC EXAMINATION OF THE RETURNED BALLOON NOTED SOME CRIMPING INDENTATIONS WERE VISIBLE ON THE PROFILE OF THE BALLOON INDICATING THAT THE STENT HAD BEEN CRIMPED ON THE BALLOON. NO FURTHER DAMAGE WAS NOTED ON THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX). A 2.50X38MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHILE PREPARING A 2.25X24MM PROMUS ELEMENT STENT TO BE IMPLANTED IN THE LCX, THE PHYSICIAN NOTICED THAT THERE WAS NO STENT MOUNTED ON THE BALLOON CATHETER. A 2.25X20MM PROMUS ELEMENT STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX). A 2.50X38MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHILE PREPARING A 2.25X24MM PROMUS ELEMENT STENT TO BE IMPLANTED IN THE LCX, THE PHYSICIAN NOTICED THAT THERE WAS NO STENT MOUNTED ON THE BALLOON CATHETER. A 2.25X20MM PROMUS ELEMENT STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49608 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324220 0015264714

    Patients

    Seq Age Sex Outcome Treatment
    1