BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS UNKNOWN

    MDR report key: 2211517 · Received August 15, 2011

    Report

    Report Number
    9616099-2011-00642
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    September 14, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    WHEN THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO CROSS A CALCIFIED LESION IN THE RENAL ARTERY, IT WAS REPORTED THAT THE STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN PLACED A WIRE THROUGH THE STENT AND WAS ABLE TO PARTIALLY WITHDRAW THE STENT INTO THE GUIDE CATHETER. THE PHYSICIAN THEN SNARED THE STENT AND WHILE PULLING THE GUIDE CATHETER AND SHEATH OUT OF THE PATIENT'S ARTERY THE STENT BECAME STUCK IN THE SUBCUTANEOUS TISSUE OUTSIDE OF THE ARTERY WHERE IT REMAINS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO DEPLOY A 5MM PALMAZ GENESIS STENT ON AN AVIATOR BALLOON DURING A RENAL CASE. HE USED AN OSTIAL PRO DEVICE AS WELL. THE STENT DISLODGED FROM THE BALLOON WHEN IT WOULD NOT CROSS A CALCIFIED LESION IN THE RENAL ARTERY. THE PHYSICIAN HAD TO WIRE THROUGH THE STENT AND WAS ABLE TO GET THE STENT PARTIALLY INTO THE GUIDE CATHETER. THE PHYSICIAN THEN SNARED THE STENT AND WHEN PULLING THE GUIDE AND SHEATH OUT OF THE PATIENT'S ARTERY THE STENT GOT STUCK IN THE SUBCUTANEOUS TISSUE OUTSIDE OF THE ARTERY. THE STENT WAS LEFT IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention