BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2029926 · Received March 25, 2011

    Report

    Report Number
    2024168-2011-02054
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 28, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT - ESTIMATED; REPORTED AS (B)(6) 2011 GUIDE WIRE .035 TERUMO; INFLATION DEVICE: ABBOTT;, SHEATH: 6 FR CORDIS. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. POTENTIAL FACTORS WHICH MAY CONTRIBUTE TO A SELF EXPANDING STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, AN INTERACTION WITH THE PATIENT ANATOMY AND/OR PREVIOUSLY IMPLANTED STENTS, POST DILATATION TECHNIQUE OR STENT SIZE SELECTION. THOUGH REQUESTED, NO CINE IMAGES WERE PROVIDED. CINE IMAGES MAY HAVE AIDED IN DETERMINING A CAUSE FOR THE REPORTED DIFFICULTY. BASED ON THE REPORTED INFORMATION THAT THE STENT MOVED PROXIMAL WITH THE DILATOR OF THE STARCLOSE SE SHEATH, IT MAY BE POSSIBLE THAT AN UNDERSIZED STENT WAS SELECTED CAUSING POOR WALL APPOSITION AND INTERACTION WITH THE CLOSURE DEVICE SHEATH DISRUPTED THE STENT PLACEMENT. A CONCLUSIVE CAUSE FOR THE DIFFICULTY COULD NOT BE DETERMINED. HOWEVER, BASED ON THE CASE DESCRIPTION, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT RELATED TO A POTENTIAL MANUFACTURING OR PRODUCT DEFICIENCY, ALL SELF EXPANDING STENTS ARE CONFIRMED BY VARIOUS QUALITY CHECKS TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS, INCLUDING PROPER STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT. THE STARCLOSE SE IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE BIFURCATION OF THE COMMON AND SUPERFICIAL FEMORAL ARTERY, THE ABSOLUTE STENT WAS DEPLOYED WITHOUT REPORTED ISSUE. POST STENT IMPLANT, THE STARCLOSE SE WAS USED FOR ARTERIOTOMY CLOSURE; HOWEVER, THE ABSOLUTE STENT WAS MOVED PROXIMAL WITH THE DILATOR OF THE STARCLOSE SE SHEATH. IT WAS SUSPECTED BY THE PHYSICIAN THAT THE RADIAL FORCE OF THE ABSOLUTE STENT WAS NOT FULL/EQUALLY APPOSED TO THE VESSEL WALL DISTAL AND PROXIMAL. THERE WAS NO REPORTED PATIENT EFFECT. THERE WAS NO ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1