BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3043553 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02152
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) WITH STENT RECEIVED INSIDE A WISEGUIDE GUIDE CATHETER. THERE WAS BLOOD ON THE STENT AND IN THE BALLOON FOLDS. THE PROMUS ELEMENT PLUS SDS AND STENT WERE PROTRUDING FROM THE DISTAL END OF THE WISEGUIDE GUIDE CATHETER 2.5CM. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT MOVED DISTALLY PAST THE MARKERBAND ON THE BALLOON. THE PROXIMAL END OF THE STENT WAS DAMAGED AND EXHIBITED NUMEROUS BENT AND FLARED STRUTS. THE PROMUS ELEMENT PLUS SDS WAS PROTRUDING FROM THE PROXIMAL END OF THE WISEGUIDE GUIDE CATHETER 44CM AND HAD MULTIPLE SHAFT KINKS. AN ATTEMPT WAS MADE TO REMOVE THE PROMUS ELEMENT PLUS SDS FROM THE WISEGUIDE GUIDE CATHETER; HOWEVER, COULD NOT BE REMOVED DUE TO THE DAMAGED STENT. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT OR CONFIRMED DAMAGE. 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 A STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY. USING TWO 185CM PT2 GUIDE WIRES AND A 7FR WISE GUIDE CATHETER, THE PHYSICIAN ADVANCED THE 4.00X38MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM AND WAS NOT ABLE TO CROSS THE LESION. UPON REMOVAL THE STENT BUMPED INTO THE GUIDE CATHETER AND THE STENT MOVED OFF OF THE BALLOON. THE STENT REMAINED ON THE DELIVERY SYSTEM AND WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED BY IMPLANTING TWO SMALLER STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY. USING TWO 185CM PT2 GUIDE WIRES AND A 7FR WISE GUIDE CATHETER, THE PHYSICIAN ADVANCED THE 4.00X38MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM AND WAS NOT ABLE TO CROSS THE LESION. UPON REMOVAL THE STENT BUMPED INTO THE GUIDE CATHETER AND THE STENT MOVED OFF OF THE BALLOON. THE STENT REMAINED ON THE DELIVERY SYSTEM AND WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED BY IMPLANTING TWO SMALLER STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146879 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911438400 15381374

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR