BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3822521 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02747
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 23, 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

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. SOLIDIFIED CRYSTALS WERE EVIDENT WITHIN THE BALLOON. THE CRIMPED STENT WAS DETACHED FROM BALLOON AND NOT RETURNED WITH DEVICE FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ON HYPOTUBE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT PROFILE. 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 IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY BYPASS ARTERY. A 4.00X20MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT WAS DEPLOYED TO THE TARGET LESION. POST-DILATION WAS PERFORMED USING A 4.0X12MM UNSPECIFIED BALLOON CATHETER, WHICH PASSED THE STENT WITHOUT SIGNIFICANT RESISTANCE. FOLLOWING POST-DILATION IT WAS NOTICED THAT THE STENT WAS "TOTALLY" FORESHORTENED. THE PHYSICIAN THEN SELECTED ANOTHER PROMUS ELEMENT AND DEPLOYED IT PROXIMAL TO THE FIRST STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY BYPASS ARTERY. A 4.00X20MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT WAS DEPLOYED TO THE TARGET LESION. POST-DILATION WAS PERFORMED USING A 4.0X12MM UNSPECIFIED BALLOON CATHETER, WHICH PASSED THE STENT WITHOUT SIGNIFICANT RESISTANCE. FOLLOWING POST-DILATION IT WAS NOTICED THAT THE STENT WAS "TOTALLY" FORESHORTENED. THE PHYSICIAN THEN SELECTED ANOTHER PROMUS ELEMENT AND DEPLOYED IT PROXIMAL TO THE FIRST STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303745 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918420400 16149334

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention