BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1253093 · Received December 5, 2008

    Report

    Report Number
    2953200-2008-01125
    Event Type
    Injury
    Date Received
    December 5, 2008
    Report Date
    November 5, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: THROMBOSIS.

    Description of Event or Problem · 1

    ENDEAVOR DES IMPLANTATIONS WERE SUCCESSFULLY PERFORMED IN 99 PATIENTS (65 MALES (65.6%), 34 FEMALES (33.7%), AVERAGE AGE 62+-12 YEARS) BETWEEN 2005 AND 2006. THE DIAGNOSTIC CORONARY ANGIOGRAPHY PROVED MULTI-CORONARY DISEASE IN 59 PATIENTS (59.6%). NINETY PATIENTS WERE TREATED WITH ONE STENT, TWO STENTS WERE IMPLANTED IN SIX PATIENTS, WHEREAS THREE PATIENTS RECEIVED THREE ENDEAVOR STENTS. ENDEAVOR STENT IMPLANTATION HAS BEEN SUCCESSFUL IN 98% OF CASES; TWO STENTS COULD NOT BE IMPLANTED BECAUSE OF TECHNICAL DIFFICULTIES. BESIDES ENDEAVOR, OTHER TYPES OF STENTS WERE USED IN 40 PATIENTS (41.4%) (THREE DESS, 37BMSS). MULTI-VESSEL PTCA WAS PERFORMED IN 20 CASES, IN THE OTHER 20 PATIENTS ENDEAVOR AND ANOTHER STENT HAVE BEEN IMPLANTED IN THE SAME CORONARY ARTERY. IN THE AGGREGATE, 166 STENTS WERE IMPLANTED IN 99 PATIENTS (1.67 STENTS/PATIENTS). PATIENTS WERE FOLLOWED AT THE TIME OF THE INITIAL EVENT AND AFTER 1, 3, 6, AND 12 MONTHS WITH TREADMILL EXERCISE TESTING OR ASCERTAINMENT OF STATUS BY TELEPHONE. THE AVERAGE ENDEAVOR STENT LENGTH WAS 23.16MM, THE AVERAGE STENT DIAMETER WAS 2.98 MM. THE LOCALIZATION OF THE IMPLANTED STENTS WAS AS FOLLOWS: LAD: 61 (25 PROXIMALLY), CX: 11 RCA: 21 (FOUR INTO THE ORIFICE), LEFT MAIN (LM): THREE, GRAFTS (SAPHENAVEIN GRAFT OR LEFT INTERNAL MAMMARY ARTERY): THREE. TWENTY NINE STENTS WERE IMPLANTED IN BIFURCATIONAL LESIONS (LAD DIAGONAL, DOMINANT OBTUSE MARGINAL-CIRCUMFLEXUS-OBTUSE MARGINAL), RECANALIZATION OF CHRONIC TOTAL OCCLUSIONS WITH ENDEAVOR STENT HAS BEEN PERFORMED IN ONE CASE. ALL PATIENTS WERE TREATED WITH THE COMBINATION OF 100 MG ACETYLSALICYLIC ACID AND 75 MG CLOPIDOGREL FOR 12 MONTHS. THE COMBINATION THERAPY OF GLYCOPROTEIN IIB/IIIA RECEPTOR BLOCKERS AND INTRAVENOUS NA-HEPARIN WAS USED IN 14 PATIENTS FOR 12 H AFTER PERCUTANEOUS CORONARY INTERVENTION. DURING THE FOLLOW-UP PERIOD, PLANNED (30 PATIENTS), OR UNPLANNED (SIX PATIENTS), CORONARY ANGIOGRAPHY WAS PERFORMED IN 36 PATIENTS (36.4%). TARGET VESSEL REVASCULARIZATION WAS NECESSARY IN 13 PATIENTS (13.1%) (SIX CORONARY ARTERY BYPASS GRAFT, SEVEN RE-PTCA), 11 PATIENTS HAD THREE VESSEL DISEASE, NINE HAD LAD-DIAGONAL BIFURCATIONAL LESIONS, ONE SCALABLE VECTOR GRAPHICS, ONE LM AND TWO RIGHT CORONARY ARTERY. FIVE OF 13 SUFFERED FROM DIABETES. ALL STENTS EXCEPT THE ONES IMPLANTED IN THE LM WERE LONGER THAN 18MM (DIAMETER RANGED FROM 2.75 TO 3.5MM). SIGNIFICANT RESTENOSIS (NEED FOR TARGET LESION REVASCULARIZATION) WAS OBSERVED IN EIGHT PATIENTS (8.1%). SUBACUTE STENT THROMBOSIS (WITHIN 10 DAYS) OCCURRED IN TWO PTS (2.0%). ANY LATE THROMBOSIS WAS NOT OBSERVED. FIVE PATIENTS DIED DURING THE FOLLOW-UP PERIOD: TWO PATIENTS DUE TO PROGRESSION OF HEART FAILURE (NO RESTENOSIS), ONE PATIENT AFTER A HUGE STROKE, ONE PATIENT DIED DURING AN EPISODE OF ALCOHOL ABUSE. NON-ST ELEVATION MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK BECAUSE OF RESTENOSIS CAUSED THE DEATH OF ONE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention