BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1790281 · Received August 6, 2010

    Report

    Report Number
    3004742046-2010-00351
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ABSOLUTE .035 SELF EXPANDING STENT SYSTEM INDICATED WAS FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: THE SELF EXPANDING STENT SYSTEM (SES) WAS RETURNED WITH BLOOD ON THE HANDLE AND ON THE TIP. THERE WAS NO SALINE VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE SHAFT, BUT HAD MOVED DISTALLY FOR A LENGTH OF 4.5 MM DISTAL TO THE PROXIMAL MARKER BAND. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE DISTAL OUTER SHEATH WAS WRINKLED FOR A LENGTH OF 4.5 MM DISTAL TO THE PROXIMAL MARKER BAND. THERE WAS NO OTHER DAMAGE NOTED TO THE SES. THERE WERE NO KINKS NOTED TO THE SES AS REPORTED. THE HANDLE WAS IN THE LOCKED POSITION. ANALYSIS OF THE RETURNED DEVICE DID NOT CONFIRM A SHAFT KINK AS REPORTED; HOWEVER, THE DISTAL OUTER SHEATH WAS WRINKLED DISTAL TO THE PROXIMAL MARKER BAND. THIS DAMAGE CAN BE THE RESULT OF, BUT NOT LIMITED TO, MANUFACTURING, HANDLING DURING REMOVAL FROM PACKAGING AND/OR HANDLING DURING PREPARATION FOR USE. ANALYSIS ALSO NOTED THAT THE STENT IMPLANT WAS STATIONARY, BUT HAD MOVED DISTALLY WITH NO DAMAGE NOTED. THIS DAMAGE WAS NOT ORIGINALLY REPORTED AND IS LIKELY A RESULT OF HANDLING OF THE DEVICE. IN THIS CASE IT IS POSSIBLE THAT DURING REMOVAL OF THE STYLET, PRESSURE MAY HAVE BEEN APPLIED OVER THE STENT AND SHEATH SUCH THAT THE STENT MOVED DISTALLY. FURTHER HANDLING LIKELY CONTRIBUTED TO THE DISTAL OUTER SHEATH WRINKLING; HOWEVER, THIS CANNOT BE CONFIRMED. ALTHOUGH THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, A CONCLUSIVE CAUSE FOR THE NOTED WRINKLED SHAFT AND MISPLACED STENT COULD NOT BE DETERMINED. ALL ABSOLUTE PRO DEVICES ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND DAMAGE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT MOVEMENT. TIME OF DEVICE ISSUE: DURING DEVICE PREPARATION. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING A SUPERIOR MESENTERIC ARTERY STENTING PROCEDURE AN ABSOLUTE PRO WAS OPENED, BUT DUE TO A KINK IN THE DISTAL SHAFT THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED STENT. DEVICE ANALYSIS REVEALED THE STENT HAD MOVED DISTALLY AND WAS MISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 9052851

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR GUIDE WIRE: UNSPECIFIED 0.014 GUIDE WIRE| ABSOLUTE .035 SELF EXPANDING STENT SYSTEM.| UNSPECIFIED SNARE DEVICE