BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1211738 · Received October 24, 2008

    Report

    Report Number
    2024168-2008-01011
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 28, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS NOT RETURNED. ONLY THE STENT IMPLANT WAS RETURNED. THERE WAS BLOOD VISIBLE ON THE STENT. THERE WAS NO CONTRAST VISIBLE. THE FIRST THREE DISTAL ROWS WERE STRETCHED OUT. THE FIRST TEN ROWS OF DISTAL STRUTS WERE SMASHED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE PROTECTIVE SHEATH WAS NOT RETURNED. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE PROXIMAL OUTER DIAMETER MEASUREMENTS MET MANUFACTURING CRITERIA. DISTAL OUTER DIAMETER MEASUREMENTS COULD NOT BE TAKEN DUE TO THE DAMAGED STENT IMPLANT. PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY, AND LESION MORPHOLOGY. REPORTEDLY, THE TARGET LESION WAS MODERATELY TORTUOUS, MILDLY CALCIFIED, AND 99% STENOSED, WHICH ALONG WITH THE PRESENCE OF ANOTHER SDS, MAY HAVE CONTRIBUTED TO THE STENT IMPLANT DISLODGEMENT. THE STENT IMPLANT WAS RETURNED TO ABBOTT VASCULAR FOR ANALYSIS, ALTHOUGH THE SDS WAS NOT RETURNED, AND THUS IT CANNOT BE DETERMINED HOW IT MAY HAVE CONTRIBUTED TO THE DISLODGEMENT. THE STENT IMPLANT WAS RETURNED WITH STRETCHED AND SMASHED STRUTS AT THE DISTAL END. DUE TO THE DAMAGE TO THE STENT IMPLANT, THE OUTER DIAMETER COULD ONLY BE MEASURED AT THE PROXIMAL END, WHERE IT MET MANUFACTURING CRITERIA. IT POSSIBLE THAT THE STENT IMPLANT BECAME DAMAGED AS IT DISLODGED, AS IT WAS SNARED WITH THE GUIDE WIRES, OR AS IT WAS PACKAGED AND SHIPPED BACK TO ABBOTT VASCULAR FOR ANALYSIS. WITH THE DAMAGE TO THE STENT IMPLANT AND WITHOUT THE SDS FOR ANALYSIS, A DEFINITE ROOT CAUSE FOR THE DISLODGEMENT CANNOT BE DETERMINED. A REVIEW OF THE DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT LOT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - REQUIRED INTERVENTION. REPORTING RATIONALE: STENT DISLODGEMENT REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT TWO XIENCE V STENTS (3.5 X 18 AND 3.5 X 12) WERE ADVANCED TO DO A KISSING STENT TECHNIQUE AT THE BIFURCATION OF THE LAD & LCX; HOWEVER, DURING POSITIONING, THE STENT OF THE XIENCE 3.5 X 18 DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) AND WENT INTO THE LAD. THE DISLODGED STENT WAS REMOVED USING TWO GUIDE WIRES AND ANOTHER XIENCE 3.5 X 18 WAS SUCCESSFULLY IMPLANTED IN THE BIFURCATION. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8040942

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention GUIDE WIRE: BMW| ALLSTAR| DILATATION CATHETER: VOYAGER