BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2091860 · Received May 17, 2011

    Report

    Report Number
    2024168-2011-03527
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH THE PATIENT ANATOMICAL INFORMATION WAS NOT PROVIDED, FAILURE TO ADVANCE IS NOT OFTEN ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. IT IS LIKELY THAT THE STENT CAUGHT ON THE TIP OF THE GUIDING CATHETER, FURTHER DAMAGING THE PROXIMAL STRUTS, CONTRIBUTING TO THE DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM (SDS) THROUGH THE GUIDING CATHETER. TO HELP ENSURE THE REPORTED DIFFICULTIES ARE NOT RELATED TO A MANUFACTURING DEFICIENCY, THE BALLOON IS CHECKED FOR PROPER FOLD CONFIGURATION, THE STENT IS CHECKED FOR PROPER STRUT DIMENSIONS, AND THE STENT IS INSPECTED AT MULTIPLE STEPS IN THE PROCESS FOR STENT DAMAGE DURING THE MANUFACTURING PROCESS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE, STENT DAMAGE, AND DIFFICULTY REMOVING THE SDS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO STENT A LESION IN THE PROXIMAL CIRCUMFLEX UTILIZING A 3.0 X 8 MM PROMUS, BUT THE STENT WOULD NOT CROSS THE AREA OF STENOSIS. THE STENT WAS RETRACTED AND DURING REMOVAL, SOME RESISTANCE WAS ENCOUNTERED AT THE GUIDING CATHETER OSTIUM. THE STENT WAS REMOVED AND INSPECTED, AND IT WAS NOTED THAT TWO OF THE STENT STRUTS HAD BEEN LIFTED. THE STENT WAS DISCARDED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS DURING THE TIME IT TOOK TO REMOVE THE FIRST PROMUS, THEN PRE-DILATE AND DEPLOY THE SECOND PROMUS. THE PATIENT'S STATUS AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. 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 0011541

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR