BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2191687 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05489
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. 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. IN THIS CASE, IT IS LIKELY THAT INTERACTION WITH THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE AND LOOSENED THE STENT ON THE BALLOON. SUBSEQUENT INTERACTION WITH THE CALCIFIED LESION DURING RETRACTION WOULD HAVE THEN LED TO THE STENT DISLODGEMENT AS THERE WAS NO DAMAGE NOTED TO THE STENT OR STENT DELIVERY SYSTEM (SDS) DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. TO ENSURE THE REPORTED DIFFICULTIES ARE NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR STENT DISLODGEMENT FOR THIS LOT. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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 THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY. THE PROMUS STENT DELIVERY SYSTEM WAS UNABLE TO CROSS THE PRE-DILATED LESION SITE AND UPON REMOVAL, THE STENT DISLODGED INTO THE PROXIMAL CX ARTERY. A BALLOON CATHETER WAS USED TO DEPLOY THE STENT AND A DIFFERENT DEVICE WAS USED TO TREAT THE DISTAL CX. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 1022341

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention