BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3953549 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04468
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 7, 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

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE DISTAL PORTION OF THE STENT BODY WERE DISTORTED, DEFORMED AND LIFTED UPWARDS FROM THE STENT PROFILE. DUE TO THE REPORTED DIFFICULTY WITHDRAWING THE DEVICE IT IS LIKELY THE DEVICE ENCOUNTERED RESISTANCE DURING WITHDRAWAL ATTEMPTS. 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. THE INNER WAS BROKEN AT THE BI-COMPONENT BOND. THE BI-COMPONENT BREAK WAS VISUALLY EVIDENT AND APPEARED AS A 133MM SEPARATION IN THE INNER DURING VISUAL EXAMINATION. THERE WAS ALSO EVIDENCE OF KINKING & STRETCHING TO THE OUTER SHAFT WALL. THIS TYPE OF DAMAGE IS LIKELY TO HAVE BEEN CAUSED BY EXCESSIVE TENSILE FORCES BEING APPLIED TO THE DELIVERY SYSTEM. THE INNER SHOWED SIGNS OF STRETCHING (NECKING) TO THE INNER, DISTAL TO THE BI-COMPONENT BOND. THIS NECKING WOULD HAVE CAUSED THE EXCESSIVE NARROWING OF THE WIRE LUMEN THUS CAUSING THE SECTION OF THE GUIDEWIRE TO BECOME "FROZEN" WITHIN LUMEN. A VISUAL AND TACTILE EXAMINATION FOUND A KINK 114MM DISTAL FROM THE STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BUMPER TIP OF THE DEVICE SHOWED SIGNS OF DAMAGE TO THE DISTAL EDGE OF THE TIP. THIS TYPE OF DAMAGE IS CONSISTENT WITH RESISTANCE BEING ENCOUNTERED ON ADVANCEMENT OF THE STENT DELIVERY CATHETER. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. IN AN UNSPECIFIED TARGET LESION, A 32 X 3.00 PROMUS PREMIER¿ STENT DELIVERY SYSTEM WAS ADVANCED. IT WAS NOTICED THAT THE DEVICE GOT STUCK ON A NON-BSC GUIDEWIRE. THE DEVICE AND THE GUIDEWIRE WAS REMOVED AS ONE UNIT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. IN AN UNSPECIFIED TARGET LESION, A 32 X 3.00 PROMUS PREMIER¿ STENT DELIVERY SYSTEM WAS ADVANCED. IT WAS NOTICED THAT THE DEVICE GOT STUCK ON A NON-BSC GUIDEWIRE. THE DEVICE AND THE GUIDEWIRE WAS REMOVED AS ONE UNIT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430600 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925132300 16858735

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: ETONA/VOLCANO