BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2863069 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07266
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 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

    DESCRIBE EVENT OR PROBLEM, DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE, CATALOG/MODEL #: UPDATED. UPN AND UPN-SEARCH CORRECTED FROM UNK634 TO H7493911324270. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS CAUSED BY OTHER DEVICE AS ANOTHER DEVICE/DRUG/SUBSEQUENT PROCEDURE CAUSED THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 2.75 X 20MM PROMUS ELEMENT WAS IMPLANTED DISTAL IN THE LESION AND THE 2.75 X 24MM PROMUS ELEMENT WAS IMPLANTED PROXIMAL IN THE LESION. THE ATLANTIS CATHETER GOT BUMPED INTO 2.75 X 24MM PROMUS ELEMENT. POST-DILATION WAS PERFORMED FOUR TIMES ON THE IMPLANTED STENTS. THERE WERE NO ISSUES WITH THE IMPLANTED STENTS' CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PREDILATATION WITH AN 2.0 X 20 MM APEX BALLOON, IVUS WAS PERFORMED. TWO STENTS, A 2.75 X 24 MM PROMUS ELEMENT AND A 2.75 X 20 MM PROMUS ELEMENT, WERE THEN IMPLANTED FROM DISTAL TO PROXIMAL IN THE TARGET LESION. THE ATLANTIS SR PRO2 IMAGING CATHETER WAS INTRODUCED FOR POST IVUS AND 'BUMPED INTO' THE PROXIMAL EDGE OF ONE OF THE PROMUS ELEMENT STENTS. THE IMAGING CATHETER CROSSED THE STENT BUT AFTER PULLBACK, STENT DEFORMATION WAS NOTED. BECAUSE THE LESION WAS NO LONGER ADEQUATELY COVERED, A NON-BSC STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED 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 H7493911324270 0014973658

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INFLATION DEVICE: ENCORE| GUIDE WIRE: RENATO| GUIDE WIRE: SION| BALLOON CATHETER: APEX 2.0 X 20 MM| STENT: PROMUS ELEMENT 2.75-20