BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2221966 · Received August 24, 2011

    Report

    Report Number
    9616099-2011-00665
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    August 9, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT(S) REMAINS IMPLANTED IN THE PATIENT AND IS/ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. WHILE NOT OBSERVED IN THE (B)(4) CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. THE CAUSE OF COMPLETE SES FRACTURE IN THE PRESENT CASE WAS MOST LIKELY MECHANICAL STRESSES RESULTING FROM CARDIAC CONTRACTIONS AS REPORTED THAT THE VESSEL WAS "MOVING LIKE A HINGE" AND A LONG LESION (69 MM IN LENGTH) TREATED WITH OVERLAPPING STENTS. THERE ARE PATIENT (DIABETES) AND VESSEL/ LESION CHARACTERISTICS (LONG LESION) THAT MAY HAVE CONTRIBUTED TO THE RESTENOSIS AS WELL. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THE EVENT DATE FOR THIS OCCURRENCE IS UNKNOWN.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REPORTED IN "SIROLIMUS-ELUTING STENT FRACTURE DETECTION BY THREE-DIMENSIONAL OPTICAL COHERENCE TOMOGRAPHY"; TAKAYUKI OKAMURA, MD, AND MASUNORI MATSUZAKI, MD; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2011. THE PATIENT WAS PRESENTED IN CASE 1. THE TARGET LESION WAS (B)(4). THE LESION WAS A DE-NOVO AND CALCIFIED, BUT IT IS UNKNOWN IF IT WAS TORTUOUS. THE % OF THE STENOSIS WAS UNKNOWN, BUT IT WAS MODERATELY STENOSED. THE PATIENT'S MEDICAL HISTORY CONSISTED OF DIABETES MELLITUS, HYPERTENSION, AND DYSLIPIDEMIA. AT AN UNKNOWN DATE, TREATMENT FOR (B)(4) WAS CONDUCTED. ROTABLATOR AND PRE-DILATION WERE CONDUCTED AND THREE CYPHER BX STENTS (2.5/28MM, 3.0/18MM, AND 3.5/23MM) WERE IMPLANTED FROM (B)(4), OVERLAPPING EACH OTHER. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. THE SUM OF THE LENGTH OF ALL THREE STENTS EQUALS 69MM. IVUS WAS CONDUCTED AND SUFFICIENT STENT APPOSITION WAS CONFIRMED. THERE WAS NO PROBLEM OBSERVED WITH THE IMPLANT. THE PATIENT EXPERIENCED NO PROCEDURE-RELATED COMPLICATIONS AND WAS DISCHARGED FROM THE HOSPITAL. A YEAR LATER AFTER THE IMPLANT: FOLLOW-UP CAG WAS CONDUCTED AND RESTENOSIS WAS OBSERVED IN THE CYPHER BX (3.5/23MM) IMPLANTED AT (B)(4) WHERE THE VESSEL WAS MOVING LIKE A HINGE. OCT WAS CONDUCTED AND MOST STENT STRUTS AT SITES PROXIMAL AND DISTAL TO THE RESTENOSIS WERE CONFIRMED TO BE COVERED WITH A THIN INTIMAL HYPERPLASIA. ON 3D CUT-AWAY IMAGES, NEARLY CONCENTRIC STENT FRACTURE WITH A GAP WAS OBSERVED AT THE RESTENOSIS SITE. IT IS UNKNOWN IF THE STENT FRACTURE WAS TREATED. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT. PHYSICIAN'S COMMENT: THE CAUSE OF THE STENT FRACTURE WAS UNKNOWN.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR