BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYTEM

    MDR report key: 1241100 · Received November 21, 2008

    Report

    Report Number
    2024168-2008-01208
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 24, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - DISSECTION, AS LISTED IN THE IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. DISSECTION IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. IT SHOULD BE NOTED THAT THE IFU ALSO STATES, "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER)."

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE LESION WAS PREDILATED USING ANOTHER COMPANY'S 2.5X12 MM BALLOON CATHETER AT 8 ATM FOR 10 SECONDS. THE STENT RUPTURED THE VESSEL WALL CAUSING A PROXIMAL EDGE DISSECTION, WHICH WAS CONFIRMED BY IVUS. AFTER INFLATING ANOTHER COMPANY'S 3.0 X 8 MM BALLOON; THE DISSECTION WAS TREATED WITH A 3.5 X 23 MM PROMUS STENT. INITIALLY, THERE WAS AN IRREGULAR EKG, UPON TREATMENT OF THE DISSECTION, THE EKG WAS NORMAL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELLING OF ABBOT 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 SYTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8061861

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention OTHER: ATLANTIS 40MHZ CORONARY IVUS CATHETER| DIL CATH: 2.5X12 MAVERICK