BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4190105 · Received October 21, 2014

    Report

    Report Number
    2134265-2014-06268
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 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 COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS, HOWEVER THE SHAFT OF THE DEVICE WAS BROKEN AND THE PROXIMAL PORTION WAS NOT RETURNED. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THAT THE CRIMPED STENT HAD MOVED DISTALLY ON THE BALLOON AND THE DISTAL PORTION AND THE MAJORITY OF THE PROXIMAL PORTION OF THE STENT WAS DAMAGED AND BUNCHED WITH THE DISTAL PORTION MOVED OUT OVER THE TIP OF THE DEVICE. THE TYPE OF DAMAGE EVIDENT TO THE CRIMPED STENT IS CONSISTENT WITH THE COMPLAINT REPORT. THE BALLOON CONES PROFILE 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 HAD BEEN ACHIEVED BETWEEN THE COATED STENT AND BALLOON. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKING ON THE DISTAL PORTION OF THE HYPOTUBE SHAFT THAT WAS RETURNED AND THE SHAFT ITSELF WAS BROKEN IN THE REGION (18MM DISTAL TO BREAK) OF A SEVERE KINK. THE HYPOTUBE BROKE 1009MM PROXIMAL FROM THE DEVICE TIP. A VISUAL AND TACTILE EXAMINATION OF SHAFT POLYMER EXTRUSION 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS:MDR#2134265-2014-06269. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). A CALCIFIED DIFFUSE LESION WAS NOTED BETWEEN DISTAL RCA AND PROXIMAL RCA. PREDILATION WAS PERFORMED PRIOR TO STENTING. A NON-BSC STENT WAS ADVANCED; HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. A NON-BSC GUIDE CATHETER WAS USED TO RESOLVE THE ISSUE; HOWEVER, THE NON-BSC STENT WAS STILL UNABLE TO CROSS THE LESION. A 16X3.5MM PROMUS PREMIER¿ STENT WAS SELECTED; HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE STENT WAS DEFORMED. A 12X3.5MM PROMUS PREMIER¿ STENT WAS THEN SELECTED; HOWEVER, THE DEVICE COULD NOT CROSS THE LESION. IT WAS NOTED THAT THE STENT WAS DEFORMED INSIDE THE NON-BSC GUIDE CATHETER. THE PROXIMAL EDGE OF THE GUIDE CATHETER WAS FOUND TO TURN UP TOWARDS THE INNER LUMEN. A 3.0MM PROMUS PREMIER¿ STENT WAS SUCCESSFULLY DEPLOYED IN THE DISTAL RCA USING A NEW NON-BSC GUIDE CATHETER. SUBSEQUENTLY, TWO MORE UNSPECIFIED SIZE PROMUS PREMIER¿ STENT WERE DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS:MDR#2134265-2014-06269. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). A CALCIFIED DIFFUSE LESION WAS NOTED BETWEEN DISTAL RCA AND PROXIMAL RCA. PREDILATION WAS PERFORMED PRIOR TO STENTING. A NON-BSC STENT WAS ADVANCED; HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. A NON-BSC GUIDE CATHETER WAS USED TO RESOLVE THE ISSUE; HOWEVER, THE NON-BSC STENT WAS STILL UNABLE TO CROSS THE LESION. A 16X3.5MM PROMUS PREMIER¿ STENT WAS SELECTED; HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE STENT WAS DEFORMED. A 12X3.5MM PROMUS PREMIER¿ STENT WAS THEN SELECTED; HOWEVER, THE DEVICE COULD NOT CROSS THE LESION. IT WAS NOTED THAT THE STENT WAS DEFORMED INSIDE THE NON-BSC GUIDE CATHETER. THE PROXIMAL EDGE OF THE GUIDE CATHETER WAS FOUND TO TURN UP TOWARDS THE INNER LUMEN. A 3.0MM PROMUS PREMIER¿ STENT WAS SUCCESSFULLY DEPLOYED IN THE DISTAL RCA USING A NEW NON-BSC GUIDE CATHETER. SUBSEQUENTLY, TWO MORE UNSPECIFIED SIZE PROMUS PREMIER¿ STENT WERE DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT SHAFT SEPARATION OF BOTH DEVICES OCCURRED AT THE HUB OF THE NON-BSC GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668761 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925116350 16782610

    Patients

    Seq Age Sex Outcome Treatment
    1