BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1932126 · Received December 17, 2010

    Report

    Report Number
    9616099-2010-00990
    Event Type
    Injury
    Date Received
    December 17, 2010
    Report Date
    November 22, 2010
    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

    AMERICAN HEART JOURNAL 2010; 160:775.E1-775.E9 "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THIS LITERATURE IS FROM (B)(6) HOSPITAL AND(B)(6) MEDICAL UNIVERSITY. THIS CASE IS 6TH 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 RCA BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN ISR NOR CTO LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, CYPHER BX (3.0/33MM AND LOT UNKNOWN) WAS IMPLANTED. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP (6-9MONTHS AFTER THE IMPLANT) ANGIOGRAM, THE STENT FRACTURE AND RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN FRACTURE SITE AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL TYPE. THE %DS WAS 72% AND POPMA ET AL CLASSIFICATION WAS II. TO TREAT THE RESTENOSIS, TAXUS (DETAILS UNKNOWN) WAS IMPLANTED. AFTER THAT, NO RECURRENT RESTENOSIS WAS OBSERVED. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. 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 IN-STENT 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 IN-STENT 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 IN-STENT RESTENOSIS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. PLEASE NOTE THAT THE CATALOG NUMBER IS NOT KNOWN. THE CATALOG NUMBER ENTERED REPRESENTS AN UNKNOWN CYPHER SIROLIMUS-ELUTING CORONARY (B)(4) STENT. THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9, "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THE LITERATURE IS FROM (B)(6) HOSPITAL AND (B)(6) MEDICAL UNIVERSITY. THE PATIENT WAS ADMITTED TO THE INDEX PROCEDURE WITH STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS NEITHER AN IN-STENT RESTENOSIS (ISR) NOR A CTO LESION. A 3.0 X 33MM CYPHER BX STENT WAS IMPLANTED AT THE TARGET LESION. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6-9MONTHS AFTER THE IMPLANT AND REVEALED STENT FRACTURE AND RESTENOSIS. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN THE FRACTURE SITE AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL. THE DIAMETER STENOSIS (DS) OF THE TARGET LESION WAS 72%. THE POPMA ET. AL. CLASSIFICATION WAS II. TO TREAT THE RESTENOSIS, A TAXUS STENT WAS IMPLANTED. AFTER THAT, NO RECURRENT RESTENOSIS WAS OBSERVED. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE 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 65 YR Hospitalization| R