BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS MULTI-LINK CORONARY STENT SYSTEM

    MDR report key: 2296675 · Received October 14, 2011

    Report

    Report Number
    2024168-2011-06970
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    August 24, 2010
    Report Date
    September 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DINA O. HALWANI, MD, ET AL; CLINICAL DEVICE RELATED ARTICLE, SURFACE CHARACTERIZATION OF EXPLANTED ENDOVASCULAR STENTS: EVIDENCE OF IN VIVO CORROSION, PUBLISHED WILEY ONLINE LIBRARY 2010; 225-238. FACTORS THAT CAN CONTRIBUTE TO THE STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE DURING USE OF THE PRODUCT, AN INTERACTION WITH THE PATIENT ANATOMY AND/OR PREVIOUSLY IMPLANTED STENTS, POST DILATATION TECHNIQUE, OR UNDERSIZING OF THE VESSEL. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT RELATED TO A POTENTIAL MANUFACTURING OR PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS (SDS) ARE CONFIRMED BY VARIOUS QUALITY CHECKS TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS, INCLUDING PROPER BALLOON DIMENSIONS, AND PROPER STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER INFLATION AND STENT DEPLOYMENT. THERE WAS NO NOTE OF ANY DAMAGE TO THE SDS OR STENT IMPLANT OBSERVED PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. IT WAS NOTED IN THE ARTICLE REVIEW THAT THE IMPROPER EMBEDDING OF THE STENT MAY HAVE CAUSED UNEVEN DISTRIBUTION OF THE STENT STRUTS; HOWEVER, THIS COULD NOT BE CONFIRMED. ADDITIONALLY, IT WAS NOTED THAT SOME OF THE STENT STRUTS WERE MISSING WHICH LIKELY OCCURRED DUE TO THE REGROWTH OF CALCIFICATION IN THE VESSEL; HOWEVER, THIS COULD NOT BE CONFIRMED. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE PART AND LOT NUMBERS WERE NOT REPORTED. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES WAS UNABLE TO BE DETERMINED; HOWEVER THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A TOTAL OF 16 EXPLANTED STENTS FROM NINE INDIVIDUAL CASES WERE ANALYZED, ONE OF WHICH WAS A MULTI-LINK DUET. THE PURPOSE OF THE CONTROLLED EXPERIMENT WAS TO ASSESS THE CORROSIVE NATURE OF THE CHEMICAL SELECTED FOR TISSUE DISSOLUTION BY EXPOSING STENTS BEFORE APPLYING ON THE RETRIEVED SPECIMENS CONTAINING THE EXPLANTED STENT. THE MULTI-LINK STENT HAD BEEN IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY ON AN UNKNOWN DATE. THE VESSEL CONTAINING THE STENT WAS REMOVED DURING AUTOPSY FOLLOWING DEATH ON (B)(6) 2006. THE CAUSE OF DEATH WAS SEPSIS. THE STENT WAS NOT FRACTURED; HOWEVER, IT WAS CUT INTO TWO SEGMENTS FOR HISTOLOGY. HISTOPATHOLOGICAL ASSESSMENT OF ONE SEGMENT SHOWED ECCENTRIC ZONES OF CALCIFICATION LOCATED BEHIND THE STENT STRUTS, INDICATING THAT THEY EXISTED BEFORE STENT PLACEMENT, WHICH COMPRESSED THEM AGAINST THE VESSEL WALL. THE STENT STRUTS WERE NOT UNIFORMLY DISTRIBUTED WITH SOME STRUTS MISSING. IT IS LIKELY THAT IMPROPER EMBEDDING MAY HAVE CAUSED THIS UNEVEN DISTRIBUTION OF THE STRUTS. THE SECOND SEGMENT OF THE STENT WAS RELATIVELY UNALTERED EXCEPT FOR LOCALIZED REGION CONTAINING ABRASION AND PITTING MARKS SUGGESTED TO BE CAUSED BY A CREVICE, WHICH MAY HAVE FORMED BY CALCIFICATION. ELEMENTAL SURFACE ANALYSIS OF THIS REGION SHOWED A DECREASE IN SURFACE NICKEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS MULTI-LINK CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR