BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141810 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04513
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 2, 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. A MISLOCATED AND DAMAGED STENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, INADEQUATE CRIMPING DURING MANUFACTURING, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING DURING PRODUCT PREPARATION FOR USE, OR INTERACTION WITH ACCESSORY DEVICES. RETURN OF THE PROMUS STENT DELIVERY SYSTEM (SDS) MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO INCIDENTS REPORTED FOR MISLOCATED STENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED MISLOCATED AND DAMAGED STENT CANNOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. A SAMPLING OF UNITS IS ALSO SUBJECTED TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY. 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 DURING DEVICE UNPACKAGING THE PROTECTIVE CAP (SHEATH) WAS REMOVED AND THE STENT IMPLANT WAS FOUND TO HAVE FLARED STENT STRUT. ADDITIONALLY, THE STENT WAS TIGHTLY CRIMPED BUT WAS MOVED DISTALLY ON THE BALLOON TOWARD THE MARKER. THE DEVICE WAS NOT USED IN THE ANATOMY. 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 1020741

    Patients

    Seq Age Sex Outcome Treatment
    1