BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2840782 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07143
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A BREAK AT THE MIDSHAFT. IT WAS ALSO NOTED THAT THE LUMEN WAS SEVERELY KINKED IN VARIOUS LOCATIONS THROUGHOUT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE CRIMPED STENT WAS ALSO DAMAGED THROUGHOUT. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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). 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY STENTING PROCEDURE A STENT DELIVERY SYSTEM WAS STUCK ON THE GUIDE WIRE AND THE SHAFT DETACHED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD), RIGHT CORONARY (RCA), OR OBTUSE MARGINAL (OM) ARTERIES. THE 2.75 X 24 MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FROZE ON THE MID SECTION OF THE UNSPECIFIED GUIDE WIRE. THEY REMOVED THE DEVICES TOGETHER AND REMOVED THE SDS OFF THE GUIDE WIRE WITH "GREAT FORCE". THE CATHETER SHAFT WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH 3 PROMUS ELEMENT STENTS WITH 1 EACH PLANTED IN THE LAD, RCA, AND OM ARTERIES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY STENTING PROCEDURE A STENT DELIVERY SYSTEM WAS STUCK ON THE GUIDE WIRE AND THE SHAFT DETACHED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD), RIGHT CORONARY (RCA), OR OBTUSE MARGINAL (OM) ARTERIES. THE 2.75 X 24MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FROZE ON THE MID SECTION OF THE UNSPECIFIED GUIDE WIRE. THEY REMOVED THE DEVICES TOGETHER AND REMOVED THE SDS OFF THE GUIDE WIRE WITH "GREAT FORCE". THE CATHETER SHAFT WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH 3 PROMUS ELEMENT STENTS WITH 1 EACH PLANTED IN THE LAD, RCA, AND OM ARTERIES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324270 15073495

    Patients

    Seq Age Sex Outcome Treatment
    1