BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1862006 · Received October 8, 2010

    Report

    Report Number
    9616099-2010-00777
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 6, 2008
    Report Date
    September 10, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. MYOCARDIAL INFARCTION AND STENT THROMBOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. STENT UNDER-EXPANSION IS MOST OFTEN RELATED TO VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS SUCH AS NOT POST DILATING THE STENT FOR OPTIMAL STENT WALL APPOSITION. 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. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION AND ALSO IN SITUATIONS WHEN IMPLANTED WITH HIGH INFLATION PRESSURES. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. STENT FRACTURE HAS BEEN RECOGNIZED AS A POTENTIAL MECHANISM OF THROMBOSIS AND RESTENOSIS AND MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. WITHOUT THE PROCEDURAL CD THE STENT FRACTURE COULD NOT BE CONFIRMED AND WITHOUT IVUS THE STENT MALAPPOSITION COULD NOT BE CONFIRMED. WITH THE VERY LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE THE EXACT FACTORS THAT CONTRIBUTED TO THE EVENTS, BUT THERE ARE PATIENT FACTORS (SURGERY) AND/OR POSSIBLE PROCEDURAL AND/OR VESSEL/LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CONCLUSION WAS REVISED BELOW. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. MYOCARDIAL INFARCTION AND STENT THROMBOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WHILE POSITIVE VESSEL REMODELING HAS PREVIOUSLY BEEN ASSOCIATED WITH BIFURCATING LESIONS, PLAQUE DISTRIBUTION IN THE LESION AND BRACHYTHERAPY, REVIEW OF CURRENT LITERATURE DEMONSTRATES SOME AUTHORS SUGGEST DRUG-ELUTING STENTS MAY HAVE THE SAME POTENTIAL RISKS AS BRACHYTHERAPY, IN TERMS OF THE ANTI-PROLIFERATIVE EFFECTS ON VASCULAR SMOOTH MUSCLE CELLS AND ENDOTHELIAL CELLS. 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. 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. STENT FRACTURE HAS BEEN RECOGNIZED AS A POTENTIAL MECHANISM OF THROMBOSIS AND RESTENOSIS AND MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. WITHOUT THE PROCEDURAL CD THE STENT FRACTURE COULD NOT BE CONFIRMED AND WITHOUT IVUS THE STENT MALAPPOSITION COULD NOT BE CONFIRMED. WITH THE VERY LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE THE EXACT FACTORS THAT CONTRIBUTED TO THE EVENTS, BUT THERE ARE PATIENT FACTORS (SURGERY) AND/OR VESSEL/LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TARGET LESION WAS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY(LAD). THE LESION WAS A DE NOVO, BUT OTHER LESION INFORMATION WAS UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. THE LESION LENGTH WAS APPROXIMATELY 25MM AND THE VESSEL DIAMETER WAS APPROXIMATELY 3.0MM. IT WAS AN ELECTIVE CASE. IT IS UNKNOWN IF PRE-DILATION WAS CONDUCTED. CYPHER BX (3.0/28MM) WAS IMPLANTED AT 25ATM (INFLATION TIME UNKNOWN) AT THE TARGET LESION. IT IS UNKNOWN IF POST-DILATION WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS UNKNOWN. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WERE UNKNOWN. IVUS WAS NOT CONDUCTED. IT IS UNKNOWN IF ACT WAS MEASURED. ELEVEN DAYS POST-PROCEDURE, THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS OF THE KNEE. APPROXIMATELY 3 WEEKS POST-PROCEDURE, THE PATIENT DEVELOPED ST-ELEVATED MI. CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE CYPHER BX. AT THE SAME TIME, STENT FRACTURE WAS OBSERVED AT THE IMPLANTED CYPHER BX AND POSITIVE REMODELING WAS ALSO CONFIRMED AT THE VESSEL AROUND THE IMPLANTED CYPHER BX. TO TREAT THE THROMBUS, ASPIRATION AND POBA WERE CONDUCTED. IN ADDITION, A BMS (NON-CORDIS, SIZE UNKNOWN) WAS IMPLANTED INSIDE THE CYPHER BX. TREATMENT FOR THE STENT FRACTURE AND THE POSITIVE REMODELING WAS UNKNOWN. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT THE EFFECT OF THE STENT FRACTURE AND INSUFFICIENT STENT APPOSITION DUE TO POSITIVE REMODELING.

    Description of Event or Problem · 1

    THE TARGET LESION WAS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY(LAD). THE LESION WAS A DE NOVO, BUT OTHER LESION INFORMATION WAS UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. THE LESION LENGTH WAS APPROXIMATELY 25MM AND THE VESSEL DIAMETER WAS APPROXIMATELY 3.0MM. IT WAS AN ELECTIVE CASE. IT IS UNKNOWN IF PRE-DILATION WAS CONDUCTED. CYPHER BX (3.0/28MM) WAS IMPLANTED AT 25ATM (INFLATION TIME UNKNOWN) AT THE TARGET LESION. IT IS UNKNOWN IF POST-DILATION WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS UNKNOWN. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WERE UNKNOWN. IVUS WAS NOT CONDUCTED. IT IS UNKNOWN IF ACT WAS MEASURED. ELEVEN DAYS POST-PROCEDURE, THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS OF THE KNEE. APPROXIMATELY 3 YEARS POST-PROCEDURE, THE PATIENT DEVELOPED ST-ELEVATED MI. CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE CYPHER BX. AT THE SAME TIME, STENT FRACTURE WAS OBSERVED AT THE IMPLANTED CYPHER BX AND POSITIVE REMODELING WAS ALSO CONFIRMED AT THE VESSEL AROUND THE IMPLANTED CYPHER BX. TO TREAT THE THROMBUS, ASPIRATION AND POBA WERE CONDUCTED. IN ADDITION, A BMS (NON-CORDIS, SIZE UNKNOWN) WAS IMPLANTED INSIDE THE CYPHER BX. TREATMENT FOR THE STENT FRACTURE AND THE POSITIVE REMODELING WAS UNKNOWN. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT THE EFFECT OF THE STENT FRACTURE AND INSUFFICIENT STENT APPOSITION DUE TO POSITIVE REMODELING.

    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 64 YR Hospitalization| L| R ASPIRIN AND CLOPIDOGREL