BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4223276 · Received November 4, 2014

    Report

    Report Number
    2134265-2014-06614
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 PROXIMAL PORTION OF THE CRIMPED STENT WERE DAMAGED, DISTORTED & BUNCHED DISTALLY. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONE PROFILES 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. 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 PROFILE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). AFTER PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED, THE 24 X 2.25 PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION, HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT AND IT WAS NOTED THAT A PART OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25 X 20 PROMUS PREMIER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). AFTER PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED, THE 24 X 2.25 PROMUS PREMIER⠄RUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION, HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT AND IT WAS NOTED THAT A PART OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25 X 20 PROMUS PREMIER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706163 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925124220 16782609

    Patients

    Seq Age Sex Outcome Treatment
    1