BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1919772 · Received December 10, 2010

    Report

    Report Number
    9616099-2010-00933
    Event Type
    Injury
    Date Received
    December 10, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO TREAT THE RESTENOSIS, THE PATIENT UNDERWENT CORONARY ARTERY BYPASS SURGERY (CABG). AFTER TREATMENT, THE PATIENT'S CLINICAL OUTCOME WAS EVENT FREE. DUAL ANTI-PLATELET THERAPY WAS NOT CONDUCTED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (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

    NO FURTHER INFORMATION ABOUT THE PATIENT, PROCEDURE OR EVENT COULD BE OBTAINED. COMPLAINT CONCLUSION: LITERATURE REVIEW: IT WAS REPORTED VIA 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" THAT A PATIENT EXPERIENCED STENT FRACTURE WITH SEPARATION AND RESTENOSIS. THIS CASE IS 4TH 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 CIRCUMFLEX ARTERY, BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS AN IN-STENT RESTENOSIS, BUT WAS NOT A CHRONIC TOTAL OCCLUSION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, A 3.0 X 23MM CYPHER BX WAS IMPLANTED. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP ANGIOGRAM (6 TO 9 MONTHS AFTER THE IMPLANT), THE STENT FRACTURE AND 90% FOCAL RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN FRACTURE SITE. POPMA ET AL CLASSIFICATION WAS III (COMPLETE SEPARATION WITHOUT DISPLACEMENT). TO TREAT THE RESTENOSIS, THE PATIENT UNDERWENT CORONARY ARTERY BYPASS SURGERY (CABG). AFTER TREATMENT, THE PATIENT'S CLINICAL OUTCOME WAS EVENT FREE. DUAL ANTI-PLATELET THERAPY WAS NOT CONDUCTED. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THE DEVICE WAS IMPLANTED AND, THEREFORE, NOT AVAILABLE TO ANALYSIS. NO STERILE LOT NUMBER INFORMATION WAS AVAILABLE THEREFORE NO DHR COULD BE CONDUCTED. STENT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CYPHER STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE CORONARY ARTERIES. THE CORONARY ARTERIES ARE VERY DYNAMIC VESSELS THAT UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT STENT FRACTURES OCCUR IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. THE CYPHER STENT WAS IMPLANTED TO TREAT INSTENT STENOSIS OF A PREVIOUSLY PLACED STENT. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THERE ARE LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE PRESENCE OF PREVIOUS DISEASE WITH INSTENT RESTENOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA 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" THAT A PATIENT EXPERIENCED STENT FRACTURE AND SEPARATION AND RESTENOSIS. (B)(6). THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS IN THE CIRCUMFLEX ARTERY, BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS AN IN-STENT RESTENOSIS, BUT WAS NOT A CHRONIC TOTAL OCCLUSION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, A 3.0 X 23MM CYPHER BX WAS IMPLANTED. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP ANGIOGRAM (6 TO 9MONTHS AFTER THE IMPLANT), THE STENT FRACTURE AND 90% FOCAL RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN FRACTURE SITE. POPMA ET AL CLASSIFICATION WAS III (COMPLETE SEPARATION WITHOUT DISPLACEMENT).

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R