BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERFLEX P3 8MM X 4CM, 80CM

    MDR report key: 629318 · Received August 22, 2005

    Report

    Report Number
    9610978-2005-01557
    Event Type
    Injury
    Date Received
    August 22, 2005
    Date of Event
    August 9, 2005
    Report Date
    August 22, 2005
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT (AGE UNK) WAS PRESENTED TO THE INTERVENTIONAL LAB FOR A STENTING PROCEDURE OF THE LEFT COMMON ILIAC ARTERY. THE VESSEL WAS DESCRIBED AS HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND CONTAINED A 90% STENOSIS. THE PHYSICIAN ATTEMPTED TO ACCESS THE LESION USING AN IPSILATERAL, RETROGRADE APPROACH. WITHOUT PRE-DILATION, THE PHYSICIAN ATTEMPTED TO DEPLOY A PALMEZ STENT. WHEN THE PHYSICIAN ATTEMPTED TO POSITION THE STENT DELIVERY SYSTEM (SDE) AT THE TARGET LESION HE FOUND A LEAKAGE OF CONTRAST MEDIA FROM THE BALLOON OF THE SDS. THE STENT WAS NOT DEPLOYED AND WAS REMOVED FROM THE PATIENT WITHOUT INJURY. THE PHYSICIAN INSERTED THE PF-P3 BALLOON AND WITH THE USE OF AN INDEFLATOR, THE VESSEL DISSECTED. THE PHYSICIAN PLACED A 10MM X 4CM WALL-STENT TO SUCCESSFULLY REPAIR THE DISSECTION. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 8MM X 4CM, 80CM PTA CATHETERS LIT CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R