BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3972613 · Received August 1, 2014

    Report

    Report Number
    2134265-2014-04641
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE DISTAL PORTION OF THE CRIMPED STENT WERE DISTORTED, DEFORMED, STRETCHED AND LIFTED UPWARDS FROM THE STENT PROFILE. THIS TYPE OF DAMAGE IS CONSISTENT WITH RESISTANCE BEING ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE DEVICE TO THE LESION SITE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES 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. 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. IN (B)(6) 2014, PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME (ACS) IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS SECOND SEGMENT OF THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN FIRST TREATED THE LAD AND PROCEEDED TO DILATE THE RCA. A 28 X 4.00 PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ATTEMPTED TO BE DEPLOYED DIRECTLY ON THE RCA AS THE LESION "DIDN'T SEEM CALCIFIED" HOWEVER, THE DEVICE WAS UNABLE TO CROSS. FOLLOWING WITHDRAWAL, THE PHYSICIAN FOUND THAT THE STENT WAS DAMAGED. THE PHYSICIAN THEN DECIDED TO DILATE THE LESION WITH AN UNSPECIFIED BALLOON CATHETER AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. IN (B)(6) 2014, PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME (ACS) IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS SECOND SEGMENT OF THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN FIRST TREATED THE LAD AND PROCEEDED TO DILATE THE RCA. A 28 X 4.00 PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ATTEMPTED TO BE DEPLOYED DIRECTLY ON THE RCA AS THE LESION "DIDN'T SEEM CALCIFIED" HOWEVER, THE DEVICE WAS UNABLE TO CROSS. FOLLOWING WITHDRAWAL, THE PHYSICIAN FOUND THAT THE STENT WAS DAMAGED. THE PHYSICIAN THEN DECIDED TO DILATE THE LESION WITH AN UNSPECIFIED BALLOON CATHETER AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450270 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925128400 16248334

    Patients

    Seq Age Sex Outcome Treatment
    1