BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3912758 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03810
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 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 (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.; THE STENT HAD BEEN PLACED IN THE LESION SITE AND HENCE WAS NOT RETURNED FOR ANALYSIS WITH THE DEVICE. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THERE WAS BLOOD INSIDE THE BALLOON INDICATING THERE WAS A LEAK AT THE TIME OF THE PROCEDURE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. FOLLOWING AN INITIAL EXAMINATION, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON AND THIS ATTEMPT FAILED AS FLUID LEAKED FROM THE TIP OF THE DEVICE. A SECOND ATTEMPT WAS CARRIED OUT WITH THE TIP OF THE DEVICE RESTRICTED AND THE BALLOON INFLATED SUCCESSFULLY. THERE WAS NO APPARENT DAMAGE TO THE BALLOON WALL CAUSING A LEAK THROUGH THE BALLOON. THE INNER WAS BROKEN AT THE BI-COMPONENT BOND. THE BI-COMPONENT BREAK WAS VISUALLY EVIDENT AND APPEARED AS A 1MM SEPARATION IN THE INNER DURING MICROSCOPIC EXAMINATION. THERE WAS NO EVIDENCE OF STRETCHING TO THE OUTER SHAFT WALL. AS THE BI-COMPONENT BOND WAS EVIDENTLY BROKEN IT WOULD NOT HAVE BEEN POSSIBLE TO INFLATE THE BALLOON AND HENCE THE LEAKING OF FLUID THROUGH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE OF THE SHAFT. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA) CONTAINING FIBROUS PLAQUE. AFTER PREDILATATION WAS PERFORMED A 20 X 2.25 PROMUS PREMIER STENT WAS SELECTED TO TREAT THE LESION. DURING DEPLOYMENT THE BALLOON RUPTURED AT 8 ATMOSPHERES SO THE PHYSICIAN USED A 2.25MM BALLOON CATHETER TO POST DILATE THE STENT AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA) CONTAINING FIBROUS PLAQUE. AFTER PREDILATATION WAS PERFORMED A 20 X 2.25 PROMUS PREMIER¿ STENT WAS SELECTED TO TREAT THE LESION. DURING DEPLOYMENT THE BALLOON RUPTURED AT 8 ATMOSPHERES SO THE PHYSICIAN USED A 2.25MM BALLOON CATHETER TO POST DILATE THE STENT AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389584 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925120220 16742520

    Patients

    Seq Age Sex Outcome Treatment
    1