BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040551 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01236
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: VISUAL AND MICROSCOPIC EXAMINATION OF THE COMPLAINT DEVICE IDENTIFIED A BREAK IN THE HYPOTUBE, 200MM DISTAL TO THE CATHETER STRAIN RELIEF. SEVERAL KINKS WERE NOTED ALONG THE LENGTH OF THE HYPOTUBE SHAFT. THE DAMAGE NOTED IS CONSISTENT WITH EXCESSIVE TENSILE FORCE APPLIED TO THE SHAFT. THE TIP, BALLOON AND STENT SECTIONS OF THE DEVICE WERE EXAMINED AND NO ISSUES WERE NOTED 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE IN-STENT RESTENOSED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE DILATED WITH AN UNSPECIFIED BALLOON. THE PHYSICIAN THEN ADVANCED THE 2.5MM X 12MM PROMUS ELEMENT DRUG ELUTING CORONARY STENT SYSTEM HOWEVER FRICTION WAS ENCOUNTERED. AN ATTEMPT WAS MADE TO PUSH THE STENT FURTHER DOWN THE ARTERY AND THE SHAFT OF THE DEVICE BROKE OUTSIDE THE PATIENT. THE DISTAL SECTION OF THE DEVICE WAS EASILY REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN DECIDED THE DILATION WAS SUFFICIENT AND DID NOT IMPLANT A STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE IN-STENT RESTENOSED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE DILATED WITH AN UNSPECIFIED BALLOON. THE PHYSICIAN THEN ADVANCED THE 2.5MM X 12MM PROMUS ELEMENT DRUG ELUTING CORONARY STENT SYSTEM HOWEVER FRICTION WAS ENCOUNTERED. AN ATTEMPT WAS MADE TO 'PUSH THE STENT FURTHER DOWN THE ARTERY' AND THE SHAFT OF THE DEVICE BROKE OUTSIDE THE PATIENT. THE DISTAL SECTION OF THE DEVICE WAS EASILY REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN DECIDED THE DILATION WAS SUFFICIENT AND DID NOT IMPLANT A STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312250 0013847426

    Patients

    Seq Age Sex Outcome Treatment
    1