BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040261 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02382
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER- CORRECTED FROM 1009540-15B TO 1009540-12B. FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY DEPLOYING A STENT CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, LESION CHARACTERISTICS, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE, PRODUCT SIZE SELECTION, AND/OR LESION SIZE. THE PRODUCT WAS NOT RETURNED AND MAY HAVE AIDED IN THE INVESTIGATION. IT IS POSSIBLE THAT THE 80% STENOSED, MODERATELY CALCIFIED LESION CONTRIBUTED TO THE REPORTED DIFFICULTY TO DEPLOY. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR DIFFICULT TO DEPLOY FOR THIS LOT. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT AND NOT A PRODUCT QUALITY DEFICIENCY. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION DURING MANUFACTURING. ADDITIONALLY, A SAMPLING OF UNITS FROM EVERY LOT IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DEPLOYMENT DIMENSIONS, AS WELL AS STENT UNIFORMITY OF EXPANSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE OSTIAL LEFT ANTERIOR DESCENDING ARTERY WITH CALCIFICATION AND 80% STENOSIS. THE PROMUS STENT WAS ATTEMPTED TO BE DEPLOYED AT 16 ATMOSPHERES. NO ISSUES WITH INFLATING THE STENT DELIVERY BALLOON WERE REPORTED. HOWEVER, THE STENT WAS NOTED TO BE ONLY PARTIALLY EXPANDED AND NOT FULLY APPOSED, WITH A WAIST IN THE MID PART OF THE STENT. FOUR NON-ABBOTT BALLOONS WERE INFLATED INSIDE THE STENT, BUT THE STENT WAS STILL NOT FULLY APPOSED. ANOTHER NON-ABBOTT BALLOON (3.0 X 10 MM) WAS ATTEMPTED, BUT IT WOULD NOT CROSS. THEN ANOTHER NON-ABBOTT BALLOON WAS USED TO ATTEMPT TO EXPAND THE STENT, WITHOUT SUCCESS. THE PROCEDURE ENDED WITH THE STENT ONLY PARTIALLY APPOSED. 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 0111561

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention