BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1211534 · Received October 22, 2008

    Report

    Report Number
    2024168-2008-00995
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 26, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT SHOULD BE NOTED THAT THE PROMUS IFU STATES, "PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED." PERFORATION, AS LISTED IN THE IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS KNOWN PATIENT EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. PERFORATION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: PERFORATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE 4.0 X 23 MM PROMUS STENT WAS IMPLANTED DISTALLY, WITH AN OVERLAP, TO THE STENT THAT WAS IMPLANTED DURING A PREVIOUS PROCEDURE. IT DID NOT APPEAR THAT PRE-DILATATION WAS PERFORMED. THE BALLOON CATHETER WAS PULLED BACK AND THE BALLOON WAS RE-INFLATED AT THE OVER-LAP OF THE PROMUS AND THE PREVIOUSLY PLACED STENT. UPON DEFLATION ANGIO WAS TAKEN, AND A PERFORATION OF THE VEIN GRAFT WAS NOTED. THIS WAS TREATED WITH A COVERED STENT AND SUBSEQUENTLY TWO STENTS, FROM ANOTHER COMPANY, WERE IMPLANTED PROXIMALLY TO THE PREVIOUSLY PLACED STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE DOING FINE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION 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 8032561

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention