BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1919735 · Received December 10, 2010

    Report

    Report Number
    9616099-2010-00929
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011. ONLY 1 OF THE 2 STENTS WAS FRACTURED. THIS COMPLAINT IS FROM THE AMERICAN HEART JOURNAL (2010; 160:775.E1-775.E9) ARTICLE ENTITLED 'SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION.' THIS CASE IS 22ND OF 29 EVENTS. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING (LAD), BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN IN-STENT RESTENOSIS, BUT IT WAS A CHRONIC TOTAL OCCLUSION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, TWO CYPHER BX STENTS (SIZE AND LOT NUMBER UNKNOWN) WERE IMPLANTED. THE TOTAL STENTED LENGTH WAS 47MM AND THE STENT DIAMETER WAS 3.0MM. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6 TO 9MONTHS AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED, BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE PERCENTAGE DIAMETER OF STENOSIS WAS 14% AND POPMA ET AL CLASSIFICATION WAS II (V-FORM). THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ONLY ONE OF THE TWO STENTS WAS FRACTURED. REOCCLUSION/RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. STENT DAMAGE/DEFORMATION AND RESTENOSIS/REOCLUSSION ARE KNOWN ADVERSE EVENTS INDICATED IN THE IFU. WHILE NOT OBSERVED IN THE PIVOTAL 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. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS. HOWEVER, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00928 AND 9616099-2010-00929. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Additional Manufacturer Narrative · 1

    THE STENT FRACTURE WAS OBSERVED, BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE PERCENTAGE DIAMETER OF STENOSIS WAS 14% AND POPMA ET AL CLASSIFICATION WAS II (V-FORM). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00928 AND 9616099-2010-00929. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED STENT FRACTION AND 14% OCCLUSION OF TWO CYPHER STENTS. THIS COMPLAINT IS FROM THE AMERICAN HEART JOURNAL (2010; 160:775.E1-775.E9) ARTICLE ENTITLED "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION". THIS CASE IS 22ND OF 29 EVENTS. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING (LAD), BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN IN-STENT RESTENOSIS, BUT IT WAS A CHRONIC TOTAL OCCLUSION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, TWO CYPHER BX STENTS (SIZE AND LOT NUMBER UNKNOWN) WERE IMPLANTED. THE TOTAL STENTED LENGTH WAS 47MM AND THE STENT DIAMETER WAS 3.0MM. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6 TO 9 MONTHS AFTER THE IMPLANT.

    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 55 YR