BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2122326 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04145
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 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. GUIDE WIRE: NS RUNTHROUGH. GUIDE CATH: HEARTRAIL 6F. 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 DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE AND STENT DAMAGE AS 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 LESION/ANATOMY DURING RETRACTION, DAMAGING THE PROXIMAL STRUTS, AND CONTRIBUTING TO THE RESISTANCE DURING RETRACTION. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT RELATED TO A POTENTIAL MANUFACTURING OR PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. THE LESION WAS LOCATED DISTAL TO A PREVIOUSLY PLACED STENT IN THE DISTAL RCA. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED, AND THE LESION WAS PRE-DILATED. THE PROMUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT IT COULD NOT CROSS A TORTUOUS AREA OF THE PROXIMAL TO MID RCA. DILATATION WAS PERFORMED, AND ANOTHER ATTEMPT WAS MADE TO ADVANCE THE SDS; HOWEVER, IT WAS UNABLE TO CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS MET WITH THE VESSEL; HOWEVER, NO RESISTANCE WAS MET WITH THE GUIDING CATHETER. AFTER REMOVAL, IT WAS OBSERVED THAT THE PROXIMAL STENT STRUTS WERE FLARED. THE PROCEDURE WAS LEFT AT BALLOONING ONLY. THE PATIENT WAS STABLE AND SCHEDULED FOR ANOTHER CORONARY INTERVENTION AT A LATER DATE. THERE WERE NO 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 0112641

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR