BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2160857 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04956
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 2.75 X 23 MM PROMUS IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. 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. A LOOSE 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. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING OR PRODUCT RELATED DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% 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. RETURN OF THE STENT DELIVERY SYSTEM MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR LOOSE STENTS FOR THIS LOT. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. ANALYSIS NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, ON THE BALLOON AND STENT IMPLANT, CONSISTENT WITH HANDLING AND THE STENT DELIVERY SYSTEM (SDS) AT LEAST PARTIALLY ADVANCED OVER A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THE STENT WAS NOT LOOSE AS REPORTED. THERE WERE STRETCHED STRUTS ON THE FIRST ROW AT THE DISTAL END OF THE STENT IMPLANT. THE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. FACTORS THAT CAN CONTRIBUTE TO STENT DAMAGE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, REMOVAL OF THE PROTECTIVE SHEATH, HANDLING OF THE PRODUCT, OR INTERACTION OF THE SDS WITH ACCESSORY DEVICES OR ANATOMY. TO HELP ENSURE THIS TYPE OF EVENT IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL SDS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, INCLUDING AT THE POINT THAT THE PROTECTIVE SHEATH IS PLACED OVER THE BALLOON. CONSIDERING THE EXTENT OF THE DAMAGE (STRETCHED), IT IS UNLIKELY THAT THIS WAS A PRE-EXISTING CONDITION AS THE PROTECTIVE SHEATH WOULD NOT HAVE FIT OVER THE STENT IMPLANT. IT IS UNKNOWN WHEN THE STENT DAMAGE OCCURRED BUT IT IS POSSIBLE THAT THE DAMAGE OCCURRED DURING HANDLING OF THE PRODUCT DURING PREPARATION FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY, A 2.75 X 18 PROMUS STENT AND A 2.75 X 23 PROMUS STENT WERE FOUND TO BE LOOSE ON THE BALLOON OUTSIDE OF THE ANATOMY. THE STENT SYSTEMS WERE NO LONGER USED AND THE PROCEDURE WAS COMPLETED USING A NEW UNSPECIFIED DEVICE. THERE WAS NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 0082641

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR