BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3885869 · Received June 20, 2014

    Report

    Report Number
    9616099-2014-00395
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY ANTONSEN ET AL INTIMAL HYPERPLASIA AND VASCULAR REMODELING AFTER EVEROLIMUS-ELUTING AND SIROLIMUS-ELUTING STENT IMPLANTATION IN DIABETIC PATIENTS: THE RANDOMIZED DIABETES AND DRUG-ELUTING STENT (DIABETES) IV INTRAVASCULAR ULTRASOUND TRIAL, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 83 (2014) 864-872; ONE STENT FRACTURE WAS SEEN AND OCCURRED IN A PATIENT WITH RESTENOSIS AFTER 10 MONTHS. AT THE INDEX PROCEDURE, THIS CYPHER STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY WITH 16 ATMOSPHERES WITH POST DILATION IN A PATIENT WITH A NON-STEMI AND AN OCCLUDED RIGHT CORONARY ARTERY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. THE CURVATURE OF THE SVG DURING CARDIAC CONTRACTIONS WITH PERIVASCULAR ADHESION AND FIBROSIS IN THE LIMITED INTRA-THORACIC SPACE MAY INDUCE HIGH MECHANICAL STRESSES AT THE OSTIAL SVG. THE CAUSE OF COMPLETE SES FRACTURE IN THE PRESENT CASE WAS MOST LIKELY MECHANICAL STRESSES RESULTING FROM CARDIAC CONTRACTIONS. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING PATIENT¿S WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDED THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE LONG LESIONS WITH OVERLAPPING STENTS AND CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. BASED ON THE LIMITED INFORMATION PROVIDED BY THE PATIENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENTS. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. HOWEVER, ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THE ROOT CAUSE AND DETERMINE IF ANY CORRECTIVE ACTIONS ARE NEEDED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONTINUED FROM EVENT DESCRIPTION: UNFRACTIONATED HEPARIN WAS GIVEN INTRAVENOUSLY AT THE BEGINNING OF THE PROCEDURE. AFTER THE INTERVENTION, CLOPIDOGREL 75MG PER DAY AND ASPIRIN 75 MG PER DAY WERE CONTINUED FOR 12 MONTHS AND LIFELONG, RESPECTIVELY. IVUS WAS PERFORMED AFTER ADMINISTRATION OF INTRACORONARY NITROGLYCERIN. THE IVUS SYSTEM USED A 40 MHZ, 2.6F IVUS CATHETER (ATLANTIS-PRO). THE IVUS ENDPOINTS WERE IN-STENT IH PERCENTAGE VOLUME, IN-STENT % VOLUME OBSTRUCTION, AND CHANGES IN EXTERNAL ELASTIC MEMBRANE (EEM) VOLUME. IVUS DATA WERE AVAILABLE FOR PATIENTS RETURNING FOR A FOLLOW-UP IVUS AFTER 10 MONTHS. PATIENTS WITHOUT IVUS DATA WERE EXCLUDED FROM THE INTENTION-TO-TREAT ANALYSIS. 139 DIABETIC PATIENTS WERE RANDOMIZED TO EES (N=72) OR SES IMPLANTATION (N=67). FOLLOW-UP IVUS WERE NOT PERFORMED FOR CLINICAL OR TECHNICAL REASONS IN 18 PATIENTS (EES N=8, SES N=10). IN THIS PATIENT, UPPER PANEL SHOWED IVUS IMAGES POST PROCEDURE FROM THE STENTED SEGMENT DISTAL TO PROXIMAL. LOWER PANEL IMAGE SHOWED CORRESPONDING IVUS IMAGES AT FOLLOW-UP FROM THE STENTED SEGMENT DISTAL TO PROXIMAL SHOWING INTIMA HYPERPLASIA AND A CROSS SECTION WITH A STENT FRACTURE WHERE ONLY ONE SINGLE STENT STRUT WAS VISIBLE. CONCOMITANT DEVICES: PRE- AND POST-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN. UNFRACTIONATED HEPARIN WAS GIVEN DURING THE PROCEDURE. THIS ARTICLE WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: ANTONSEN, L ET AL (2014, MAY, 1). INTIMAL HYPERPLASIA AND VASCULAR REMODELING AFTER EVEROLIMUS-ELUTING AND SIROLIMUS-ELUTING STENT IMPLANTATION IN DIABETIC PATIENTS: THE RANDOMIZED DIABETES AND DRUG-ELUTING STENT (DIABETES) IV INTRAVASCULAR ULTRASOUND TRIAL. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 83, 864-872. THE GENDER OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY ANTONSEN ET AL INTIMAL HYPERPLASIA AND VASCULAR REMODELING AFTER EVEROLIMUS-ELUTING AND SIROLIMUS-ELUTING STENT IMPLANTATION IN DIABETIC PATIENTS: THE RANDOMIZED DIABETES AND DRUG-ELUTING STENT (DIABEDES) IV INTRAVASCULAR ULTRASOUND TRIAL, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 83 (2014) 864-872; ONE STENT FRACTURE WAS SEEN AND OCCURRED IN A PATIENT WITH RESTENOSIS AFTER 10 MONTHS. AT THE INDEX PROCEDURE, THIS CYPHER STENT (3.5X28MMM) WAS IMPLANTED IN THE RIGHT CORONARY ARTERY WITH 16 ATMOSPHERES (ATM) WITH POST DILATION (4.0MM NONCOMPLIANT BALLOON) IN A PATIENT WITH A NON-STEMI AND AN OCCLUDED RIGHT CORONARY ARTERY. 139 PATIENTS WITH DIABETES MELLITUS AND ANGIOGRAPHICALLY SIGNIFICANT CORONARY STENOSES IN NATIVE CORONARY ARTERIES (VESSEL DIAMETER 2.25-4.0MM) WERE ENROLLED IN A PREPLANNED SUBSTUDY (THE DIABEDES IV STUDY) OF THE SORT OUT IV TRIAL. EXCLUSION CRITERIA WERE LESIONS IN VEIN GRAFTS AND EXPECTED SURVIVAL <1 YEAR. PATIENTS WERE CONSIDERED TO HAVE DIABETES, IF THEY RECEIVED DIETARY TREATMENT, ORAL ANTIDIABETIC MEDICATION, OR INSULIN. PATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE A SES (CYPHER SELECT) OR AN EES (XIENCE V)BY TELEPHONE CONTACT TO A COMPUTER-GENERATED RANDOMIZATION SEQUENCE IN THE SORT OUT IV TRIAL. PATIENTS WERE STRATIFIED BY HOSPITAL AND BY THE PRESENCE/ABSENCE OF DIABETES. THE RANDOMLY ASSIGNED STENT WAS IMPLANTED IN ALL LESIONS TREATED. IN MULTI-VESSEL INTERVENTION, LESION LOCATION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS SELECTED AS STUDY LESION. IN COMBINED CIRCUMFLEX AND RIGHT CORONARY ARTERY INTERVENTIONS, THE RIGHT CORONARY LESION WAS USED AS THE STUDY LESION. IF MORE THAN ONE LESION WAS TREATED IN THE SAME VESSEL, THE PROXIMAL LESION WAS CHOSEN AS THE STUDY LESION. ONLY ONE LESION (STUDY LESION) FOR EACH PATIENT WAS ANALYZED. PRIOR TO INTERVENTION, THE PATIENTS WERE TREATED WITH A 300-600MG CLOPIDOGREL LOADING DOSE AND CONTINUED TREATMENT WITH ASPIRIN 75MG DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363617 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4.0MM NONCOMPLIANT BALLOON