BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2153731 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04797
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 14, 2011
    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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITH BLOOD ON THE STENT IMPLANT, IN THE DISTAL SHEATH AND ON THE HANDLE. THE STENT IMPLANT WAS STATIONARY ON THE SHAFT BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THERE WAS NO DAMAGE NOTED TO THE SESS. THE HANDLE LOCK WAS IN THE LOCKED POSITION. THERE WAS NO KINK NOTED AT THE PROXIMAL END OF THE STENT AS REPORTED. DURING FUNCTIONAL TESTING, THE SESS WAS FLUSHED WITH A NEW STYLET INSERT THROUGH THE TIP AND FLUID WAS OBSERVED LEAKING AT A TEAR IN THE OUTER MEMBER 3.4 CM PROXIMAL TO THE DISTAL END OF THE OUTER MEMBER. THERE WAS AN APPEARANCE OF SCRATCHES ON THE INNER SURFACE OF THE OUTER MEMBER 9 MM DISTAL TO THE STABILIZER AND OUTER MEMBER JUNCTION FOR A LENGTH OF 7 MM. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED AT THE AREA WITH THE LEAK. THE RESULTS SUGGEST THAT THE OUTER MEMBER RUPTURE MAY POSSIBLY BE RELATED TO EXPOSURE CONDITIONS OR A MATERIAL/PROCESSING DISCREPANCY. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS FOR THIS LOT. ALL SELF EXPANDING STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM, THE DELIVERY CATHETER WAS FLUSHED AND A KINK AT THE PROXIMAL END OF THE STENT WAS SEEN. ADDITIONALLY, THE PROXIMAL END OF THE STENT SHAFT WAS NOTED TO HAVE A SMALL HOLE WITH FLUID LEAKING. THE SHAFT WAS NOT BROKEN OR SEPARATED. NO FORCE WAS APPLIED DURING DEVICE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. ANGIOPLASTY WAS PERFORMED USING A FOXCROSS .035 BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 8120551

    Patients

    Seq Age Sex Outcome Treatment
    1