BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3952218 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04264
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. THE CRIMPED STENT WAS DETACHED FROM BALLOON AND NOT RETURNED WITH DEVICE FOR ANALYSIS. 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. CRIMP MARKINGS WERE EVIDENT ON THE ENTIRE LENGTH OF THE BALLOON WALL INDICATING OVERALL CRIMP CONTACT BETWEEN THE COATED STENT AND BALLOON. THE STENT CRIMP FORCE, THE CRIMP TEMPERATURE AND THE CRIMP DURATION FOR THE DEVICE ALL ARE WITHIN THE SPECIFIED RANGE. REVIEWING THESE SPECIFIED PARAMETERS AGAINST THE BATCH RECORDS FOR THE CRIMPED UNIT, THERE ARE NO ANOMALIES EVIDENT. BASED ON THE COMPLAINT REPORT; IT IS LIKELY THAT THE STENT CAME IN CONTACT WITH THE TIP OF THE GUIDE CATHETER ON WITHDRAWAL. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE HYPOTUBE SHAFT PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND A KINK IN THE MID-SHAFT 52MM PROXIMAL FROM THE PORT BOND SKIVE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR. THE DFU STATES ¿IF UNUSUAL RESISTANCE IS FELT AT ANY TIME DURING LESION ACCESS BEFORE STENT IMPLANTATION, THE STENT SYSTEM AND THE GUIDE CATHETER SHOULD BE REMOVED AS A SINGLE UNIT.¿ ¿DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK INTO THE GUIDE CATHETER, AS STENT OR COATING DAMAGE OR STENT DISLODGMENT FROM THE BALLOON MAY OCCUR.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA) TO DISTAL RCA. THE 16 X 3.00 PROMUS PREMIER¿ DRUG-ELUTING STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION. WHEN THE PHYSICIAN REMOVED IT FROM THE BODY, THE STENT DISLODGED AT THE OSTIUM OF THE RCA. THERE WAS NO RESISTANCE WHEN MOVING THE STENT THROUGH THE GUIDE CATHETER. A BALLOON CATHETER WAS ADVANCED THROUGH THE DISLODGED STENT AND DILATED TO DEPLOY THE STENT IN THE AORTA. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA) TO DISTAL RCA. THE 16 X 3.00 PROMUS PREMIER DRUG-ELUTING STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION. WHEN THE PHYSICIAN REMOVED IT FROM THE BODY, THE STENT DISLODGED AT THE OSTIUM OF THE RCA. THERE WAS NO RESISTANCE WHEN MOVING THE STENT THROUGH THE GUIDE CATHETER. A BALLOON CATHETER WAS ADVANCED THROUGH THE DISLODGED STENT AND DILATED TO DEPLOY THE STENT IN THE AORTA. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430672 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925116300 16881661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention