BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2933233 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00450
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PREMATURE DEPLOYMENT WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS AN ENDOVASCULAR ANEURYSM REPAIR OF AN ABDOMINAL AORTIC ANEURYSM AND STENTING OF THE LEFT EXTERNAL ILIAC ARTERY. THE STENT DELIVERY SYSTEM (SDS) WAS PREPARED FOR USE WITH REMOVAL OF THE STYLET AND FLUSHING OF THE DEVICE, AFTER WHICH THE SDS WAS LOADED ONTO THE GUIDE WIRE. AS THE SDS MOVED ALONG THE GUIDE WIRE, THE OUTER SHEATH COVERING BEGAN TO EXPOSE THE STENT. THE HANDLE WAS CHECKED AND THE LOCK WAS ON. THE THUMBWHEEL WAS NOT TOUCHED. THE OUTER SHEATH COVER CONTINUED TO RETRACT ON ITS OWN, RELEASING STENT COMPLETELY BEFORE INSERTION INTO PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39553 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF-EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 2060761

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR GUIDE WIRE: LUNDEQUIST 260CM WIRE