BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ? LONG

    MDR report key: 3961412 · Received July 28, 2014

    Report

    Report Number
    2134265-2014-04381
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE 10TH, 11TH, 12TH, 18TH & 19TH ROWS (FROM DISTAL EDGE) WERE DEFORMED. THE BALLOON CONE PROFILES WERE REVIEWED WITH STRETCHING OF THE BALLOON WALL LAYERS EVIDENT DUE TO THE INCREASED SPECIFICATION DISTANCE BETWEEN THE PROXIMAL END OF THE DISTAL MARKERBAND AND THE DISTAL EDGE OF THE CRIMPED STENT. THIS TYPE OF DAMAGE IS CONSISTENT WITH DIFFICULTY TRACKING A DEVICE OVER A GUIDEWIRE SUCCESSFULLY. THE BALLOON WINGS WERE STILL TIGHTLY WRAPPED HOWEVER AND EVENLY FOLDED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE, HOWEVER THE PROFILE OF THE BALLOON WAS DISTORTED AND DISTURBED THE CRIMP PILLOWING OF THE STENT. A VISUAL AND TACTILE EXAMINATION FOUND THE INNER/OUTER SHAFT WAS SEVERELY DAMAGED WITH STRETCHING, KINKING & COMPRESSION FAILURE (PROXIMAL TO BALLOON) EVIDENT. THE STRETCHING & KINKING OCCURRED FROM PROXIMAL EDGE OF BALLOON TO 180MM PROXIMAL FROM TIP. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING USED ATTEMPTING TO ADVANCE THE DEVICE OVER A GUIDEWIRE IN A PUSH-PULL MOTION; LEADING EVENTUALLY TO TENSILE & COMPRESSION FAILURE. THE BUMPER TIP OF THE DEVICE SHOWED SIGNS OF DAMAGE TO THE ENTIRE LENGTH OF THE TIP. THE TYPE OF DAMAGE EVIDENT IS CONSISTENT WITH EXCESSIVE PUSH-PULL MOVEMENTS OVER A GUIDEWIRE WERE ATTEMPTED, LEADING TO FAILURE OF THE TIP WALL. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE HYPOTUBE SHAFT PROFILE. 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).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50X38MM PROMUS ELEMENT ¿ LONG STENT WAS SELECTED TO TREAT THE LESION. THE PHYSICIAN WAS TRYING TO LOAD THE STENT ON WIRE; HOWEVER RESISTANCE WAS ENCOUNTERED. WHEN THE PHYSICIAN PUSHED THE STENT FURTHER, IT WAS NOTED THAT THE STENT GOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50X38MM PROMUS ELEMENT ¿ LONG STENT WAS SELECTED TO TREAT THE LESION. THE PHYSICIAN WAS TRYING TO LOAD THE STENT ON WIRE; HOWEVER RESISTANCE WAS ENCOUNTERED. WHEN THE PHYSICIAN PUSHED THE STENT FURTHER, IT WAS NOTED THAT THE STENT GOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438224 PROMUS ELEMENT ? LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338350 16625828

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR