BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING STENT SYSTEM

    MDR report key: 1234097 · Received November 4, 2008

    Report

    Report Number
    9710478-2008-00151
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, DEVICE AND PATIENT INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT; SDS DID NOT INSERT INTO SHEATH. TIME OF MALFUNCTION: DURING UNPACKAGING AND DURING INSERTION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING UNPACKAGING. IT WAS NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED. AN ATTEMPT TO COMPRESS THE STENT AND INSERT IT INTO THE SHEATH WAS NOT SUCCESSFUL. THE PROCEDURE WAS ABANDONED AND THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536483 XPERT SELF-EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR SWITZERLAND NA 497288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown