BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3904228 · Received July 1, 2014

    Report

    Report Number
    2134265-2014-03708
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE PROXIMAL END OF THE CRIMPED STENT WERE DISTORTED, BUNCHED AND LIFTED UPWARDS FROM THE STENT PROFILE. 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 ON HYPOTUBE. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGED OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED BY PERFORMING ROTABLATION WITH A 1.5MM AND 1.75MM ROTABLATOR BURR. A 3.00X16MM PROMUS PREMIER STENT WAS SELECTED AND AN ATTEMPT WAS MADE TO ADVANCE THE STENT BUT THE STENT DID NOT REACH THE LESION. THEY TOOK THE STENT OUT UN-DEPLOYED AND NOTICED THAT THE STENT STRUTS AND THE EDGE OF THE STRUTS WERE FLARING OUT ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, FOLLOWED BY DEPLOYMENT OF THREE UNSPECIFIED STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGED OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED BY PERFORMING ROTABLATION WITH A 1.5MM AND 1.75MM ROTABLATOR BURR. A 3.00X16MM PROMUS PREMIER STENT WAS SELECTED AND AN ATTEMPT WAS MADE TO ADVANCE THE STENT BUT THE STENT DID NOT REACH THE LESION. THEY TOOK THE STENT OUT UN-DEPLOYED AND NOTICED THAT THE STENT STRUTS AND THE EDGE OF THE STRUTS WERE FLARING OUT ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, FOLLOWED BY DEPLOYMENT OF THREE UNSPECIFIED STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382333 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952816300 16597776

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR BURR: 1.5 ROTABLATOR BURR| BURR: 1.75 ROTABLATOR BURR