BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3626117 · Received February 13, 2014

    Report

    Report Number
    9616099-2014-00097
    Event Type
    Injury
    Date Received
    February 13, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT CONCOMITANT MEDS HAVE BEEN UPDATED IN THIS REPORT. COMPLAINT CONCLUSION: RECURRENT VERY LATE DRUG-ELUTING STENT THROMBOSIS MATTIA DUCHINI, STEPHANE FOURNIER, JUAN F. IGLESIAS, CHRISTIAN ROGUELOV, OLIVIER MULLER, ERIC EECKHOUT. INTERNATIONAL JOURNAL OF CARDIOLOGY 168 (2013) E111¿E112.N 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 OCTOBER 2006 A (B)(6) WOMAN WAS ADMITTED TO THE HOSPITAL FOR ELECTIVE PCI IN A CONTEXT OF STABLE ANGINA. RISK FACTORS INCLUDED HYPERTENSION, HYPERCHOLESTEROLEMIA AND SMOKING. ANGIOGRAPHY REVEALED A TWO-VESSEL CORONARY ARTERY DISEASE, WITH A SEVERE STENOSIS OF THE MID-LAD (FIG. 2, PANEL A) AND THE DISTAL RCA. PCI WAS PERFORMED AND A 3.5 × 23 MM CYPHER STENT WAS IMPLANTED IN THE MID-LAD WITH A GOOD FINAL ANGIOGRAPHIC RESULT. THE PATIENT WAS DISCHARGED ON DAPT. IN NOVEMBER 2008 THE PATIENT WAS ADMITTED WITH ACUTE ANTERIOR STEMI. EMERGENCY ANGIOGRAPHY REVEALED A THROMBOTIC OCCLUSION WITHIN THE CYPHER STENT (FIG. 2, PANEL B). THROMBUS ASPIRATION AND ANGIOPLASTY WERE PERFORMED. A RESIDUAL DISSECTION AT THE EXIT OF THE STENT REQUIRED THE DEPLOYMENT OF A 3.0 × 15 MM XIENCE STENT (ABBOTT VASCULAR, TEMECULA,CA, U.S.A.). THE PATIENT WAS DISCHARGED WITH THE SAME ANTIPLATELET REGIMEN AS BEFORE. IN (B)(6) 2012, FOUR YEARS AFTER THE INITIAL ST, THE PATIENT PRESENTED WITH A SECOND, RECURRENT ST (FIG. 2, PANEL C). SHE HAD ONLY BEEN UNDER ASPIRIN ANTIPLATELET THERAPY BEFORE ADMISSION. MECHANICAL THROMBECTOMY WAS REALIZED. INTRAVASCULAR ULTRASOUND (IVUS) OF THE LAD WAS CARRIED OUT, REVEALING A WELL OPPOSED XIENCE STENT BUT MALAPPOSITION OF THE CYPHER STENT. CAREFUL REVIEW OF THE DIAGNOSTIC AND THERAPEUTIC ANGIOGRAPHIC IMAGES OF 2006, DEMONSTRATED CORONARY ECTASIA AND INITIAL MALAPPOSITION. AGGRESSIVE POST-DILATATION OF THE CYPHER STENT WAS PERFORMED WITHOUT REACHING FULL APPOSITION. ECHOCARDIOGRAPHY SHOWED AN EF OF 40% WITH A LARGE ANTEROSEPTAL AND APICAL AKINESIA. A PLATELET AGGREGATION TEST WAS PERFORMED, REVEALING ADEQUATE ANTIPLATELET RESPONSE WITH A VASP INDEX OF 67% ON DAPT INCLUDING ASPIRIN AND CLOPIDOGREL. 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 OF MULTIFACTORIAL 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 RESISTANCE AND/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. MALAPPOSITION AT BASELINE MAY BE AN ADDITIONAL CAUSE OF RECURRENT ST. IN CONCLUSION, RECURRENT AND VERY LATE VAST WITH FIRST GENERATION DES EMERGES AS A DISTINCT BUT VERY UNCOMMON CLINICAL ENTITY, AS FAR AS ANTIPLATELET RESISTANCE HAS 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.

    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 ARTICLE HAS BEEN ATTACHED TO THIS MDR REPORT.

    Description of Event or Problem · 1

    AS PER LITERATURE ARTICLE, RECURRENT VERY LATE DRUG-ELUTING STENT THROMBOSIS, INTERNATIONAL JOURNAL OF CARDIOLOGY 168 (2013) E111-E112; APPROXIMATELY 2 YEARS AFTER IMPLANTATION OF A 3.5X23MM CYPHER STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE FEMALE PATIENT WAS ADMITTED WITH ACUTE ANTERIOR STEMI. EMERGENCY ANGIOGRAPHY REVEALED THROMBOTIC OCCLUSION WITHIN THE CYPHER STENT. THROMBUS ASPIRATION AND ANGIOPLASTY WERE PERFORMED. A RESIDUAL DISSECTION AT THE EXIT OF THE STENT REQUIRED THE DEPLOYMENT OF A 3.0X15MM XIENCE STENT. THE PATIENT WAS DISCHARGED WITH THE SAME ANTIPLATELET REGIMEN AS BEFORE. FOUR YEARS AFTER THE INITIAL ST, THE PATIENT PRESENTED WITH A SECOND, RECURRENT ST. MECHANICAL THROMBECTOMY WAS REALIZED. IVUS OF THE LAD WAS CARRIED OUT REVEALING A WELL OPPOSED XIENCE STENT BUT MALAPPOSITION OF THE CYPHER STENT. CAREFUL REVIEW OF THE DIAGNOSTIC AND THERAPEUTIC ANGIOGRAPHIC IMAGES FROM INITIAL STENT IMPLANTATION DEMONSTRATED CORONARY ECTASIA AND INITIAL MALAPPOSITION. AGGRESSIVE POST-DILATATION OF THE CYPHER STENT WAS PERFORMED WITHOUT REACHING FULL APPOSITION. ECG SHOWED AN EF OF 40% WITH A LARGE ANTEROSEPTAL AND APICAL AKINESIA. THE PATIENT WAS DISCHARGED ON LIFE-LONG DAPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94802 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R| S