BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2080609 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00294
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: DEPLOYMENT OF DEVICES AT HIGH PRESSURES. STENT DEFORMATION. PT LESION MORPHOLOGY. DEPLOYMENT OF DEVICES AT HIGH PRESSURES. EVAL, CONCLUSION: AGGRESSIVE POST DILATATION ACTIVITIES. PT LESION MORPHOLOGY. DEPLOYMENT OF DEVICES AT HIGH PRESSURES. EURO INTERVENTION LITERATURE 2011; 6ON-LINE PUBLISH AHEAD OF PRINT MARCH 2011. HTTP://WWW.PCRONLINE.COM/EUROINTERVENTION/AHEAD_OF_PRINT/35_04/.

    Description of Event or Problem · 1

    CLINICAL RESEARCH PAPER RESEARCHING "STENT DEFORMATION OF THE 7 CROWN ENDEAVOR / MICRO-DRIVER STENT PLATFORM (2.25-2.75MM), WHEREBY THE POST-DILATATION BALLOON CATCHES AND CAUSES MAJOR STENT DEFORMATION, ANGIOGRAPHICALLY APPEARING AS A STENT FRACTURE." THE SAMPLE SIZE WAS SET AT 1,000 CONSECUTIVE ENDEAVOR/MICRO-DRIVER STENTS (7 CROWN). A PSEUDOFRACTURE WAS DEEMED PRESENT WHEN THE OPERATOR FELT SIGNIFICANT CATCH WHEN TRYING TO PASS OR WAS UNABLE TO PASS A POST-DILATATION BALLOON. SECONDLY, ACQUISITION WITHOUT CONTRAST NEEDED TO SHOW SOME GAPPING OF THE STENT, CONFIRMED BY AN ANGIOGRAM WITH CONTRAST SHOWING LACK OF VESSEL SUPPORT AT THAT SITE. FOURTEEN STENTS DEVELOPED THE TYPICAL FEATURES OF DIFFICULTY WITH RECROSSING THEN ANGIOGRAPHIC STENT SEPARATION AND PSEUDOFRACTURE. THIS REPRESENTS AN INCIDENCE OF 1.4% IF ALL 7 CROWN STENTS DEPLOYED. GIVEN THAT STENT SEPARATION CAN ONLY OCCUR WITH POST-DILATATION, A MORE MEANINGFUL INCIDENCE MAY BE 1.8% (14 OF 775 STENTS WHERE POST-DILATATION WAS ATTEMPTED). VESSELS THAT SUFFERED STENT SEPARATION TRENDED TOWARDS MORE CALCIUM, TORTUOSITY AND LOWER STENT TO REFERENCE VESSEL RATIO. IN ORDER TO ACHIEVE A HIGH ANGIOGRAPHIC SUCCESS RATE IN 13/14 CASES (93%), THE GAP SECTION OF THE FRACTURED STENT WAS BRIDGED WITH ANOTHER STENT IN 9/14 OF CASES. IN THE FIVE CASES WHERE THE PSEUDOFRACTURE WAS NOT RE-STENTED, 30 DAY MACE OCCURRED IN THREE CASES. IN THE FIRST OF THESE CASES, A MARGINAL CX STENT COULD NEVER BE RELIABLY RE-CROSSED. THERE WAS A DISTAL DISSECTION THAT APPEARED STABLE. IT WAS THOUGHT UNLIKELY THAT A FURTHER STENT COULD BE SAFELY DELIVERED HENCE THE VESSEL WAS NOT RE-STENTED. DISTAL VESSEL OCCLUSION RESULTING IN NSTEMI OCCURRED WITHIN 24 HOURS. IN THE OTHER TWO CASES THAT WERE NOT RE-STENTED, EARLY RESTENOSIS OCCURRED AT THE SITE OF THE STENT FRACTURE WHERE THE VESSEL WAS LEFT UNSUPPORTED. BOTH CASES PRESENTED WITH ANGINA WITHOUT TP ELEVATION WITHIN 30 DAYS. SEVEN EVENTS DOCUMENTED IN THE LITERATURE STUDY PREVIOUSLY REPORTED UNDER THE FOLLOWING MFR REPORT NUMBERS: 2953200-2009-00611, 2953200-2008-00871, 2953200-2008-00629, 2953200-2008-00628, 2953200-2008-00627, 2953200-2008-00626, 2953200-2008-00625.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention