BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3628261 · Received February 14, 2014

    Report

    Report Number
    9616099-2014-00102
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    October 9, 2013
    Report Date
    January 20, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: DUCHINI ET AL (2013). RECURRENT VERY LATE DRUG-ELUTING STENT THROMBOSIS. INTERNATIONAL JOURNAL OF CARDIOLOGY, 168, E111-E112. THE LITERATURE ARTICLE HAS BEEN ATTACHED TO THIS MDR REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00101 AND 9616099-2014-00102. COMPLAINT CONCLUSION: RECURRENT VERY LATE DRUG-ELUTING STENT THROMBOSISMATTIA DUCHINI, STEPHANE FOURNIER, JUAN F. IGLESIAS, CHRISTIAN ROGUELOV, OLIVIER MULLER, ERIC EECKHOUT. INTERNATIONAL JOURNAL OF CARDIOLOGY 168 (2013) E111¿E112. STENT THROMBOSIS (ST) IS AN UNUSUAL BUT SERIOUS COMPLICATION OF PERCUTANEOUS CORONARY INTERVENTION (PCI), POTENTIALLY LEADING TOMYOCARDIAL INFARCTION AND DEATH [1]. ST IS CATEGORIZED BY THE TIME OF OCCURRENCE AFTER STENT IMPLANTATION: ACUTE (B24 H), SUB-ACUTE (B30 DAYS), LATE (B1 YEAR) AND VERY LATE (N1 YEAR), AND BY THE LEVEL OF CERTAINTY: DEFINITE, PROBABLE AND POSSIBLE [2]. THE MECHANISM OF ST IS OFTEN MULTIFACTORIAL WITH MECHANICAL, ALLERGIC OR PHARMACOLOGICAL (RESISTANCE TO ANTIPLATELET THERAPY) CAUSES [3]. A LARGE COHORT STUDY DESCRIBED LATE AND VERY LATE ST TO OCCUR IN FIRST GENERATION DES AT A STEADY ANNUAL RATE OF 0.4% TO 0.6% UP TO 4 YEARS AFTER STENT PLACEMENT [4]. THUS, IT HAS BEEN CLEARLY ESTABLISHED THAT THE RATE OF VERY LATE ST (VLST) IS HIGHER WITH FIRST GENERATION DES THAN WITH BMS [3,5]. IN THIS LETTER, WE REPORT ON 2 CASES OF RECURRENT VERY LATE ANGIOGRAPHIC ST (VAST) IN FIRST GENERATION DES IN PATIENTS WHERE ANTIPLATELET RESISTANCE WAS EXCLUDED. IN (B)(6) 2003, A (B)(6) MALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ACUTE ANTERIOR ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). RISK FACTORS INCLUDED TYPE II DIABETES, HYPERTENSION, HYPERCHOLESTEROLEMIA AND PREVIOUS SMOKING. PRIMARY PCI WAS PERFORMED FOR A CRITICAL LESION OF THE PROXIMAL LAD (FIG. 1, PANEL A) WITH IMPLANTATION OF A 3.0 × 23 MM AND 2.5 × 18 MM CYPHER STENT (CORDIS, JOHNSON & JOHNSON, BRIDGEWATER, NJ, U.S.A.) WITH A GOOD FINAL ANGIOGRAPHIC RESULT. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (DAPT): LONG TERM ASPIRIN AND CLOPIDOGREL FOR AT LEAST 12 MONTHS. IN SEPTEMBER 2004 THE PATIENT PRESENTED WITH RECURRENT ANTERIOR STEMI DUE TO A THROMBOTIC OCCLUSION WITHIN THE CYPHER STENTS (FIG. 1, PANEL B). EMERGENCY PCI (MECHANICAL THROMBUS ASPIRATION AND ANGIOPLASTY) WAS REALIZED WITH A GOOD FINAL ANGIOGRAPHIC RESULT. OF NOTE, ECHOCARDIOGRAPHY SHOWED A PRESERVED LEFT VENTRICULAR FUNCTION WITH AN EJECTION FRACTION (EF) OF 65% DESPITE ANTEROSEPTAL HYPOKINESIA. HE WAS DISCHARGED ON DAPT COMPRISING ASPIRIN AND CLOPIDOGREL FOR INDEFINITE DURATION. IN OCTOBER 2011 THE PATIENT WAS ADMITTED WITH A THIRD ANTERIOR STEMI. EMERGENCY ANGIOGRAPHY REVEALED RECURRENT ST 7 YEARS AFTER THE FIRST ST (FIG. 1, PANEL C). AGAIN, PCI WAS PERFORMED BY MEANS OF MECHANICAL THROMBUS ASPIRATION AND ADDITIONAL STENTING PROXIMAL TO THE CYPHER STENTS. A PLATELET AGGREGATION TEST WAS PERFORMED, REVEALING ADEQUATE ANTIPLATELET RESPONSE WITH AN ADEQUATE VASODILATOR-ASSOCIATED STIMULATED PHOSPHOPROTEIN (VASP) INDEX. ECHOCARDIOGRAPHY SHOWED A PRESERVED LEFT VENTRICULAR FUNCTION WITH AN EF OF 55%. THE PATIENT WAS DISCHARGED ON LIFE-LONG DAPT. THE PRODUCT(S) REMAINS IMPLANTED IN THE PATIENT AND IS/ARE THUS NOT AVAILABLE FOR EVALUATION. AS THE LOT NUMBERS WERE NOT PROVIDED, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. VERY LATE ST IN FIRST GENERATION DES IS WELL-KNOWN AND OFMULTIFACTORIAL CAUSE. IT HAS EMERGED AS A DISTINCT ENTITY, WITH SPECIFIC UNDERLYING MECHANISMS, WHICH MAINLY FEATURE DELAYED ARTERIAL HEALING AND INCOMPLETE REENDOTHELIALIZATION, OCCASIONALLY IN ASSOCIATION WITH CHRONIC INFLAMMATION, HYPERSENSITIVITY REACTION AND, AT A LATER STAGE, POSITIVE ARTERIAL REMODELING LEADING TO LATE ACQUIRED STENT MALAPPOSITION[3,6]. ANOTHER COMMON CAUSE OF ST IS ANTIPLATELET THERAPY RESISTANCEAND/OR ITS PREMATURE DISCONTINUATION [1]. OTHER, LESS PROMINENT, RISK FACTORS FOR ST HAVE ALSO BEEN IDENTIFIED: ACUTE CORONARY SYNDROME AS INITIAL PRESENTATION, MULTIVESSEL CORONARY ARTERY DISEASE, HIGHER NUMBER OF STENTS PER LESION, PRE-INTERVENTION TIMI 0 FLOW, A LOW EJECTION FRACTION, RENAL FAILURE, BIFURCATION LESIONS AND DIABETES [1,7]. UPFRONT, ANTIPLATELET RESISTANCE WAS EXCLUDED. THEREFORE, CHRONIC INFLAMMATION AND/OR PERSISTENT INCOMPLETE REENDOTHELIALIZATION MAY BE THE MAIN CAUSES OF RECURRENT ST. IN CONCLUSION, RECURRENT AND VERY LATE (SEVEN AND FOUR YEARS AFTER THE INITIAL ST IN OUR CASE REPORT) VAST WITH FIRST GENERATION DES EMERGES AS A DISTINCT BUT VERY UNCOMMON CLINICAL ENTITY, AS FAR AS ANTIPLATELET RESISTANCEHAS BEEN EXCLUDED. IN CLINICAL PRACTICE, NEWER GENERATION DES IS CURRENTLY STANDARD THERAPY. HOWEVER, A LARGE NUMBER OF PATIENTS HAVE BEEN TREATED BY FIRST GENERATION DES IN THE PAST AND REMAIN AT RISK AT ANY TIME FOR THIS UNCOMMON AND POTENTIALLY FATAL COMPLICATION DESCRIBED HERE FOR THE FIRST TIME IN THE LITERATURE. THEREFORE, FIRST GENERATION DES SHOULD PROBABLY NO LONGER BE USED AND LIFELONG DAPT SHOULD BE CONSIDERED IN PATIENTS WHO EXPERIENCED A FIRST, LATE ST. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    AS PER A LITERATURE ARTICLE, RECURRENT VERY LATE DRUG-ELUTING STENT THROMBOSIS, INTERNATIONAL JOURNAL OF CARDIOLOGY 168 (2013) E111-E112; APPROXIMATELY 18 MONTHS AFTER TWO CYPHER STENTS (3.0X23MM AND 2.5X18MM) WERE IMPLANTED IN A CRITICAL LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A GOOD FINAL ANGIOGRAPHIC RESULT. THE MALE PATIENT PRESENTED WITH RECURRENT ANTERIOR STEMI DUE TO A THROMBOTIC OCCLUSION WITHIN THE CYPHER STENTS. EMERGENCY PCI (MECHANICAL THROMBUS ASPIRATION AND ANGIOPLASTY) WAS REALIZED WITH A FOOD FINAL ANGIOGRAPHIC RESULT. THE PATIENT WAS ADMITTED WITH A THIRD ANTERIOR STEMI AND ANGIOGRAPHY REVEALED RECURRENT ST 7 YEARS AFTER THE FIRST ST. AGAIN, PCI WAS PERFORMED BY MEANS OF MECHANICAL THROMBUS ASPIRATION AND ADDITIONAL STENTING PROXIMAL TO THE CYPHER STENTS. THE PATIENT WAS DISCHARGED ON LIFE-LONG DAPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97764 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S