BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1211531 · Received October 22, 2008

    Report

    Report Number
    2024168-2008-00996
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. IN THIS INSTANCE, THE PT'S ANATOMY WAS DESCRIBED AS HEAVILY TORTUOUS, WITH A MODERATELY CALCIFIED LESION, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTIES, HOWEVER, WITHOUT THE DEVICE TO EXAMINE, A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT THE PT CAME IN FOR AN ELECTIVE PCI FOLLOWING AN ABNORMAL STRESS TEST AND UNSTABLE ANGINA. THE PT WAS GIVEN THE OPTION OF A BYPASS OR ATTEMPTED STENT PLACEMENT AND THE PT REQUESTED THE STENT PLACEMENT. THERE WAS DIFFICULTY GETTING THE STENT TO PASS A SHARP TURN, AND A WIDER GUIDE WIRE WAS USED; HOWEVER, THEN IT BECAME OBVIOUS THAT THEY COULD NOT GET THE STENT BACK. THE 2.5 X 15 MM PROMUS STENT HAD DISLODGED IN THE AREA OF THE PROXIMAL LEFT CIRCUMFLEX AND DISTAL LEFT MAIN. SEVERAL ATTEMPTS WERE MADE TO SNARE THE DEVICE; HOWEVER, ALL WERE UNSUCCESSFUL, SO THE PT WAS SENT TO SURGERY AND THE STENT WAS SUCCESSFULLY REMOVED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R| S