BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3940395 · Received July 17, 2014

    Report

    Report Number
    2134265-2014-04218
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 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 MANUFACTURER: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE DISTAL END OF THE CRIMPED STENT WAS DISTORTED 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 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. NO RESISTANCE WAS MET WHEN ATTEMPTING TO ADVANCE THIS DEVICE OVER A GUIDEWIRE. 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 COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED DISTAL OF LEFT CIRCUMFLEX. A 2.0 X 15MM EMERGE BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION AT NOMINAL PRESSURE. PRE-IVUS WAS PERFORMED USING AN OPTICROSS IMAGING CATHETER. A 28 X 2.5MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE TARGET LESION; HOWEVER THE DEVICE WAS NOT ABLE TO CROSS THE TORTUOUS AREA AT THE PROXIMAL SIDE OF THE LESION. AN ADDITIONAL NON-BSC GUIDE WIRE WAS ADVANCED AND THE 28 X 2.5MM PROMUS PREMIER¿ STENT WAS READVANCED OVER THE WIRE; BUT WAS STILL UNABLE TO CROSS. THE PHYSICIAN REPLACED THE 28 X 2.5MM PROMUS PREMIER¿ STENT TO A 2.25 X 16 MM PROMUS PREMIER¿ STENT AND WAS ABLE TO CROSS THE LESION USING AN ANCHOR BALLOON TECHNIQUE. THE STENT WAS THEN DEPLOYED IN THE LESION. THE 2.5 X 16 MM PROMUS PREMIER¿ STENT WAS THEN ADVANCED; HOWEVER THE DEVICE WAS UNABLE TO CROSS THE LESION. DURING WITHDRAWAL, THE THIS PROMUS PREMIER BECAME STUCK ON A NON-BSC GUIDE WIRE. A PROMUS ELEMENT 2.5 X 16 MM STENT WAS 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 REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED DISTAL OF LEFT CIRCUMFLEX. A 2.0 X 15MM EMERGE BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION AT NOMINAL PRESSURE. PRE-IVUS WAS PERFORMED USING AN OPTICROSS IMAGING CATHETER. A 28 X 2.5MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE TARGET LESION; HOWEVER THE DEVICE WAS NOT ABLE TO CROSS THE TORTUOUS AREA AT THE PROXIMAL SIDE OF THE LESION. AN ADDITIONAL NON-BSC GUIDE WIRE WAS ADVANCED AND THE 28 X 2.5MM PROMUS PREMIER¿ STENT WAS READVANCED OVER THE WIRE; BUT WAS STILL UNABLE TO CROSS. THE PHYSICIAN REPLACED THE 28 X 2.5MM PROMUS PREMIER¿ STENT TO A 2.25 X 16 MM PROMUS PREMIER¿ STENT AND WAS ABLE TO CROSS THE LESION USING AN ANCHOR BALLOON TECHNIQUE. THE STENT WAS THEN DEPLOYED IN THE LESION. THE 2.5 X 16 MM PROMUS PREMIER¿ STENT WAS THEN ADVANCED; HOWEVER THE DEVICE WAS UNABLE TO CROSS THE LESION. DURING WITHDRAWAL, THE THIS PROMUS PREMIER BECAME STUCK ON A NON-BSC GUIDE WIRE. A PROMUS ELEMENT 2.5 X 16 MM STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419150 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925116250 16906433

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RUNTHROUGH NS (TERUMO)| GUIDING CATHETER: RUNWAYJL4| INTRODUCER SHEATH: 6F SHEATH (TERUMO)