BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3013354 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01507
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED STENT DAMAGE. THE STENT STARTING AT THE SEVENTH ROW ON THE PROXIMAL END WAS STRETCHED DISTALLY OUT OVER ON THE TIP OF THE DEVICE. THE STENT WAS DAMAGED ALONG ITS LENGTH CAUSING SOME STRUTS TO BE RAISED UP. THE BALLOON AND THE TIP OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. THERE WERE TRACES OF BLOOD VISIBLE ON THE OUTSIDE OF THE BALLOON. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THIS 3.50X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS SELECTED AND WAS PLACED IN THE GUIDE CATHETER NO DAMAGE WAS NOTED AT THE TIME. THE PHYSICIAN CHANGED HIS MIND AND DECIDED TO TAKE OUT THE STENT FROM THE GUIDE CATHETER AND PRE-DILATE AGAIN BEFORE STENTING WITH THE SAME SDS. HOWEVER; WHEN PICKING UP THE STENT FROM STERILE FIELD THE PHYSICIAN NOTICED THAT THE STENT WAS NOT CRIMPED AS IT USUALLY WOULD BE. IT WAS FURTHER REPORTED THAT BITS OF METAL WERE RAISED AND STRETCHED OUT ON THE SDS. THE PROXIMAL PORTION OF THE STENT APPEARED TO BE STRETCHED AND DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THIS 3.50X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS SELECTED AND WAS PLACED IN THE GUIDE CATHETER NO DAMAGE WAS NOTED AT THE TIME. THE PHYSICIAN CHANGED HIS MIND AND DECIDED TO TAKE OUT THE STENT FROM THE GUIDE CATHETER AND PRE-DILATE AGAIN BEFORE STENTING WITH THE SAME SDS. HOWEVER; WHEN PICKING UP THE STENT FROM STERILE FIELD THE PHYSICIAN NOTICED THAT THE STENT WAS NOT CRIMPED AS IT USUALLY WOULD BE. IT WAS FURTHER REPORTED THAT BITS OF METAL WERE RAISED AND STRETCHED OUT ON THE SDS. THE PROXIMAL PORTION OF THE STENT APPEARED TO BE STRETCHED AND DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115144 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324350 0015406977

    Patients

    Seq Age Sex Outcome Treatment
    1