BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4111139 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05623
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THAT THE CRIMPED STENT HAD MOVED DISTALLY ON THE BALLOON AND THE DISTAL PORTION OF THE STENT WAS DAMAGED AND STRETCHED OUT OVER THE TIP OF THE DEVICE. THE TYPE OF DAMAGE EVIDENT TO THE CRIMPED STENT IS CONSISTENT WITH THE COMPLAINT REPORT AND AN UNDEPLOYED STENT EXPERIENCING CONTACT WITH ANOTHER DEVICE DURING WITHDRAWAL ATTEMPTS. THE BALLOON CONES PROFILE WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. CRIMP MARKINGS WERE EVIDENT ON THE ENTIRE LENGTH OF THE BALLOON WALL INDICATING OVERALL CRIMP CONTACT HAD BEEN ACHIEVED BETWEEN THE COATED STENT AND BALLOON. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED DIFFICULTIES MAY BE DUE INTERACTION WITH ANOTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE LEFT CIRCUMFLEX (LCX) ARTERY. A 4.00X20MM PROMUS PREMIER¿ STENT WAS SELECTED AND ADVANCED. THE PHYSICIAN WAS TRYING TO STENT THE TARGET LESION; HOWEVER, IT WAS SUSPECTED THAT THE DEVICE GOT TANGLED UP AND WAS CAUGHT UP IN AN UNSPECIFIED STENT. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT GOT STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE LEFT CIRCUMFLEX (LCX) ARTERY. A 4.00X20MM PROMUS PREMIER¿ STENT WAS SELECTED AND ADVANCED. THE PHYSICIAN WAS TRYING TO STENT THE TARGET LESION; HOWEVER, IT WAS SUSPECTED THAT THE DEVICE GOT TANGLED UP AND WAS CAUGHT UP IN AN UNSPECIFIED STENT. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT GOT STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592631 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952820400 0016705331

    Patients

    Seq Age Sex Outcome Treatment
    1