BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2882513 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-07866
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: VISUAL EXAMINATION NOTED A SHAFT BREAK LOCATED APPROXIMATELY 244MM DISTAL FROM THE CATHETERS STRAIN RELIEF. THE REMAINDER OF THE SHAFT WAS KINKED AT VARIOUS INTERVALS ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH INCREASED TENSILE FORCE HAVING BEEN APPLIED TO THE DEVICE DUE TO A RESTRICTION. MICROSCOPIC EXAMINATION OF THE STENT FOUND THAT THE PROFILE OF THE STENT WAS DISRUPTED DUE TO THE PRESENCE OF A RAISED STRUT, LOCATED IN THE MID SECTION OF THE STENT. NO FURTHER DAMAGE WAS NOTED WITH 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 OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2012-08020. IT WAS REPORTED THAT DURING STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE AND A PERFORATION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ADVANCED THE 3.50X28MM PROMUS ELEMENT STENT DELIVERY SYSTEM AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED AND IT WAS NOTED THAT SHAFT WAS KINKED AND THEN FRACTURED. THE PHYSICIAN IMPLANTED A NON-BSC IN THE TARGET LESION. THEN, THE PHYSICIAN ADVANCED THE 3.00X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM, HOWEVER, THE STENT DISLODGED. A 1.0MM BALLOON CATHETER WAS ADVANCED TO ATTEMPT TO RETRIEVE THE STENT; HOWEVER, IT WAS DEPLOYED IN THE PROXIMAL LAD. A VENTRICULAR SEPTAL PERFORATION WAS NOTED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. NO FURTHER COMPLICATIONS WERE NOTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2012-08020. IT WAS REPORTED THAT DURING STENTING TREATMENT PROCEDURE A SHAFT FRACTURE AND A PERFORATION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ADVANCED THE 3.50X28MM PROMUS ELEMENT STENT DELIVERY SYSTEM AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED AND IT WAS NOTED THAT SHAFT WAS KINKED AND THEN FRACTURED. THE PHYSICIAN IMPLANTED A NON-BSC IN THE TARGET LESION. THEN, THE PHYSICIAN ADVANCED THE 3.00X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM HOWEVER THE STENT DISLODGED. A 1.0MM BALLOON CATHETER WAS ADVANCED TO ATTEMPT TO RETRIEVE THE STENT; HOWEVER IT WAS DEPLOYED IN THE PROXIMAL LAD. A VENTRICULAR SEPTAL PERFORATION WAS NOTED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. NO FURTHER COMPLICATIONS WERE NOTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328350 14986083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 3.0X24MM PROMUS ELEMENT STENT