BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1565902 · Received December 23, 2009

    Report

    Report Number
    2024168-2009-02464
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    December 2, 2009
    Report Date
    December 4, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 2.75 X 28MM PROMUS (PART 1009528-28B LOT 8072941) HAS BEEN FILED UNDER (MRF# 2024168-2009-02461. THE 2.75 X 23 MM PROMUS (PART 100928-23B, LOT 9080441), INDICATED HAS BEEN FILED NUMBER MFR# 2024168-2009-02462. THE 2.5 X 12 MM PROMUS (PART 1009527-12B LOT 9080441), INDICATED HAS BEEN FILED NUMBER MFR# 2024168-2009-02463.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DAMAGED STENT; SUBSEQUENT REMOVAL ADDITIONAL STENT IMPLANTATION. DEVICE ISSUE: DAMAGED STENT. IT WAS REPORTED THAT THE TARGET LESIONS WERE THE LAD, LCX, OM AND RAMUS. THREE STENTS WERE SUCCESSFULLY PLACED IN THE LCX, OM AND RAMUS. THE 2.75 X 28 MM PROMUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LAD, BUT IT FAILED TO CROSS THE LESION. THE SDS WAS BEING REMOVED AND THE STENT DISLODGED FROM THE BALLOON REMAINING IN THE VESSEL. WHILE ATTEMPTING TO SNARE THE STENT IT BECAME CAUGHT ON THE PREVIOUSLY PLACED 2.75 X 23 MM PROMUS AT THE LCX. THE 2.75 X 23 MM PROMUS STENT BECAME STRETCHED AND THE DECISION WAS MADE TO REMOVE THIS STENT ALSO. DURING THE REMOVAL OF THIS STENT, THE 2.75 X 23 MM PROMUS AND 2.75 X 18 MM PROMUS PLACED IN THE OM AND RAMUS WERE STRETCHED. FINALLY, ALL FOUR OF THE STENTS WERE REMOVED, AND THE LESIONS WERE RE-STENTED NEW STENTS OF THE SAME SIZES WITHOUT ANY FURTHER COMPLICATIONS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8072141

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 2.75 X 23 PROMUS (PART 1009528-23B, LOT 8060641)| STENT: 2.75 X 28 MM PROMUS| (PART 1009528-28B, LOT 8072941)| 2.5 X 12 MM PROMUS (PART 1009527-12B, LOT 9080441)