BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2042617 · Received April 6, 2011

    Report

    Report Number
    2024168-2011-02419
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 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. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. EVALUATION SUMMARY: EVALUATION OF THE RETURNED STENT DELIVERY SYSTEM (SDS) FOUND THE STENT IMPLANT STATIONARY BETWEEN THE MARKERS OF THE TIGHTLY FOLDED BALLOON. THE ENTIRE LENGTH OF THE TIP AND STENT IMPLANT OUTER DIAMETERS MET MANUFACTURING CRITERIA. THE PROXIMAL OUTER DIAMETERS WERE MEASURED DISTAL TO THE NOTED DAMAGE. THERE WERE STRETCHED STRUTS IN THE FIRST ROW OF THE PROXIMAL END OF THE STENT IMPLANT, WHICH CONFIRMS THE REPORTED STENT DAMAGE. NO OTHER DAMAGE WAS NOTED TO THE STENT IMPLANT OR SDS. IN THIS CASE, IT WAS REPORTED THAT THE LESION WAS HEAVILY TORTUOUS AND HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO CROSS. SINCE THE PHYSICIAN REPORTED TO HAVE FELT THE RESISTANCE AT THE LESION, THE CALCIFICATION APPEARS TO HAVE ALSO CONTRIBUTED TO INTERACTION WITH THE STENT RESULTING IN STENT DAMAGE (FLARED STRUTS) DURING REMOVAL AND SUBSEQUENTLY LEADING TO THE REPORTED DIFFICULTY TO REMOVE. BASED ON THE RETURNED CONDITION, THE DISTAL FACING DIRECTION OF THE FLARED STRUTS IS CONSISTENT WITH DAMAGE THAT WOULD OCCUR FROM INTERACTION WITH CHALLENGING ANATOMY DURING REMOVAL. THE ABILITY TO CROSS A LESION CAN BE IMPACTED IN NUMEROUS WAYS. SOME OF THE CONTRIBUTING FACTORS MAY CONSIST OF, BUT NOT LIMITED ARE TO: THE PATIENTS ANATOMICAL CONDITION, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. THE REPORTED FAILURE TO CROSS, STENT DAMAGE AND DIFFICULTY TO REMOVE APPEAR TO BE RELATED TO THE PROCEDURE CIRCUMSTANCES AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROMUS RX STENT DELIVERY SYSTEM MET RESISTANCE AT THE DE NOVO AND HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY, DURING ADVANCEMENT AND REMOVAL. EXAMINATION OF THE DEVICE REVEALED THAT THE STENT HAD FLARED PROXIMAL STRUTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 0120741

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR