BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1922603 · Received December 13, 2010

    Report

    Report Number
    9616099-2010-00947
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 17, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT BELONGS TO THE SAME CLASS OF DEVICES AS THE US DISTRIBUTED CYPHER SIROLIMUS DRUG-ELUTING STENT. PLEASE NOTE: THE LOT NUMBER REPRESENTS AN UNKNOWN LOT NUMBER OF A CYPHER STENT. THE LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE IS UNKNOWN. AN INVESTIGATION IS IN PROCESS TO RETRIEVE THIS INFORMATION. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A PHYSICIAN OBSERVED A CYPHER SELECT + 3.00X18MM STENT WAS FRACTURED. IT WAS UNKNOWN WHEN THIS STENT WAS IMPLANTED. RE-PCI WAS CONDUCTED WITH THE IMPLANTATION OF AN UNKNOWN STENT. MULTIPLE ATTEMPTS TO CLARIFY THE EVENT AND RETRIEVE PRODUCT AND PROCEDURAL INFORMATION WAS UNSUCCESSFUL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS 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. THE CLINICAL IMPLICATIONS OF STENT FRACTURE ARE NOT WELL CHARACTERIZED. 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 EVENT. HOWEVER, PROCEDURAL, PATIENT, AND VESSEL/LESION CHARACTERISTICS ARE LIKELY CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A SURGEON OBSERVED IN THE IMAGE EXAM OF THE CORONARIES (CATHETERISM IN (B)(6) 2010) THERE WAS FRACTURE OF CYPHER SELECT + 3.00X18MM IMPLANTED IN THE PATIENT. THE PATIENT HAD ANOTHER ANGIOPLASTY TO PUT ANOTHER STENT AND THE PATIENT IS WITH A LOCAL INJURY IN THE VESSEL

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A SURGEON OBSERVED IN THE IMAGE EXAM OF THE CORONARIES (CATHETERIZATION ON 09/17/2010) THAT THERE WAS FRACTURE OF CYPHER SELECT + 3.00X18MM IMPLANTED IN THE PATIENT. THE PATIENT HAD ANOTHER ANGIOPLASTY TO PUT ANOTHER STENT AND THE PATIENT IS WITH A LOCAL INJURY IN THE VESSEL.

    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 Life Threatening| R