BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053430 · Received May 27, 2008

    Report

    Report Number
    9616099-2008-01395
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    October 1, 2007
    Report Date
    April 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS PATIENT HAS A HISTORY OF PREVIOUS NON Q-WAVE MI IN 2003, IDDM, HYPERTENSION, AND HYPERCHOLESTEROLEMIA, AND HE WAS ADMITTED WITH UNSTABLE ANGINA. ANGIOGRAPHY REVEALED SEVERE, EXTENSIVE TRIPLE VESSEL DISEASE. THESE FACTORS INCREASE THE PATIENT'S RISK FOR A MAJOR CARDIAC ADVERSE EVENT. IN-STENT RESTENOSIS IS A KNOWN POTENTIAL OUTCOME OF CORONARY STENTING AND IS MULTI-FACTORIAL IN ETIOLOGY. IN-STENT RESTENOSIS CAN LEAD TO MYOCARDIAL INFARCTION. SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATION OF THE STENTED AREA. WELL-KNOWN PREDICTORS ASSOCIATED WITH A HIGHER RATE OF RESTENOSIS FOLLOWING STENT IMPLANTATION INCLUDE PATIENT FACTORS SUCH AS SEX, PRIOR HISTORY OF RESTENOSIS, DIABETES, HYPERLIPIDEMIA, HYPERTENSION, UNSTABLE ANGINA, VASOSPASTIC ANGINA, RENAL DISEASE, AND SMOKING; PROCEDURAL FACTORS SUCH AS DEVICE-TO-ARTERY RATIO, PRESENCE OF SIGNIFICANT RESIDUAL GRADIENT, SIGNIFICANT RESIDUAL STENOSIS, AND THE EXTENT OF DISSECTION; AND ANGIOGRAPHIC FACTORS SUCH AS THE SIZE OF THE REFERENCE VESSEL, SEVERITY OF THE STENOSIS, PRESENCE OF CALCIUM, ECCENTRIC LESIONS, SAPHENOUS VEIN GRAFT LOCATION, OSTIAL OR PROXIMAL LESION LOCATION, AND LEFT ANTERIOR DESCENDING LESION LOCATION, AS WELL AS CHRONIC TOTAL OCCLUSION AND LONG LESIONS. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEVICE DEFECT. THERE ARE MULTIPLE PATIENT AND VESSEL/LESION FACTORS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT OF RESTENOSIS AND MI. CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #'S: 9616099-2008-01395 AND 9616099-2008-01397.

    Description of Event or Problem · 1

    A MALE PATIENT WITH A HISTORY OF PREVIOUS NON Q-WAVE MI IN 2003, IDDM, HYPERTENSION, HYPERCHOLESTEROLEMIA WAS ADMITTED FOR UNSTABLE ANGINA. HE WAS CURRENTLY TAKING BETA-BLOCKERS, ASPIRIN, HEPARIN, LIPID LOWERING AGENT, ACE-INHIBITOR, VASODILATORS, AND STATINS. ANGIOGRAPHY REVEALED THREE LESIONS, ONE IN THE DISTAL CIRCUMFLEX ARTERY (LCX), ONE IN THE PROXIMAL THROUGH MID LEFT ANTERIOR DESCENDING ARTERY (LAD), AND ONE IN THE MID RIGHT CORONARY ARTERY (RCA). THE DISTAL LCX WAS TREATED WITH THE PLACEMENT OF TWO (2) 2.5 X 18MM CYPHER STENTS DEPLOYED TO 14 ATMS AND 16 ATMS. DUE TO FATIGUE, CONTRAST VOLUME AND FLUOROSCOPIC EXPOSURE, A STAGED PROCEDURE WAS PLANNED OR THE FOLLOWING DAY TO TREAT THE LAD AND RCA. THE NEXT DAY, THE MID-RCA WAS TREATED WITH THE PLACEMENT OF A 3.0 X 18MM CYPHER STENT DEPLOYED TO 18 ATMS. DURING THE SAME PROCEDURE, THE MID LAD WAS TREATED WITH THE PLACEMENT OF A 2.5 X 23MM CYPHER STENT DEPLOYED TO 10 ATMS, AND THE PROXIMAL LAD WAS TREATED WITH THE PLACEMENT OF A 2.5 X 28MM CYPHER STENT DEPLOYED TO 16 ATMS. SATISFACTORY RESULTS WERE ACHIEVED IN ALL THREE VESSELS. THE PATIENT WAS DISCHARGED HOME WITH ORDERS FOR DAILY ADMINISTRATION OF ASPIRIN, PLAVIX, BETA-BLOCKERS, STATINS, AND ACE INHIBITORS. APPROXIMATELY FOUR YEARS AND FOUR MONTHS POST IMPLANT, THE PATIENT COMPLAINED OF A CHEST PAIN AND WAS RULED IN FOR AN ACUTE ANTERIOR WALL MI. RE-ANGIOGRAPHY REVEALED A 70-100% INSTENT RESTENOSIS OF THE 2.5 X 23MM AND THE 2.5 X 28MM CYPHER STENTS IN THE PROXIMAL THROUGH MID-LAD. THE 2.5 X 28MM CYPHER STENT IN THE PROXIMAL LAD WAS SUCCESSFULLY OPENED WITH A MAVERICK BALLOON; HOWEVER, ATTEMPTS TO OPEN THE 2.5 X 23MM CYPHER STENT IN MID-LAD WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA R0103815

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R PLAVIX| AND ACE INHIBITORS| BETA-BLOCKERS| ASPIRIN| STATINS