BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2082414 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03329
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ABILITY TO CROSS A LESION CAN BE IMPACTED IN NUMEROUS WAYS. SOME OF THE CONTRIBUTING FACTORS MAY CONSIST OF, BUT ARE NOT LIMITED TO: PATIENT ANATOMICAL CONDITION, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. IN THIS CASE, IT WAS REPORTED THAT THE LESION WAS HEAVILY TORTUOUS AND MODERATELY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO CROSS AND SUBSEQUENT STENT DAMAGE. THE DAMAGED STENT STRUTS MAY HAVE INTERACTED WITH THE DISTAL END OF THE GUIDING CATHETER DURING REMOVAL OF THE SDS SUCH THAT IT MAY HAVE CONTRIBUTED TO THE REPORTED RESISTANCE DURING RETRACTION THROUGH THE GUIDING CATHETER. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. THE REPORTED INABILITY TO CROSS, STENT DAMAGE AND DIFFICULTY DURING REMOVAL APPEARS TO BE RELATED TO PROCEDURAL CIRCUMSTANCES AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PROMUS RX STENT DELIVERY SYSTEM (SDS) MET SOME RESISTANCE AT THE LESION SITE IN THE HEAVILY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. UPON REMOVAL, THE PROMUS STENT WAS NOTED AS BEING FLARED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. FOLLOW-UP INFORMATION REPORTED THAT RESISTANCE WAS ALSO NOTED WITH THE NON-ABBOTT GUIDING CATHETER DURING REMOVAL OF THE SDS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0122141

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: MACH1 7F