BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1913016 · Received December 2, 2010

    Report

    Report Number
    3003742446-2010-00432
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2010-00433. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2010-00433. THE PATIENT CAME IN FOR ADDITIONAL TREATMENT APPROXIMATELY (B)(6) MONTHS POST INDEX PROCEDURE AND THE PHYSICIAN FOUND THE CYPHER US OTW 3.00 X 18 STENT WAS FRACTURED. A CYPHER US OTW 3.50 X 23 WAS OVERLAPPING THE 3.0 X 18 STENT IN THE RIGHT CORONARY ARTERY. THE PATIENT RECEIVED TWO OVERLAPPING CYPHER STENTS IN THE RIGHT CORONARY ARTERY (RCA). (B)(6) YEARS AFTER THE INDEX PROCEDURE, THE PATIENT CAME IN FOR ADDITIONAL TREATMENT AND THE PHYSICIAN FOUND STENT FRACTURE. THERE IS NO ADDITIONAL INFORMATION REGARDING VESSEL CHARACTERISTICS, THE IMPLANTATION OF THE STENTS, ADDITIONAL TREATMENT, STENT FRACTURE, OR DETAILS PERTAINING TO THE EVENT. THE STENTS REMAIN IMPLANTED AND REQUESTED FILMS HAVE NOT BEEN RECEIVED. THE LOT NUMBERS OF THE CYPHER STENTS ARE NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. AS OUTLINED IN THE INSTRUCTIONS FOR USE, 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. TYPICALLY THE RCA HAS MORE MOTION THAN OTHER CORONARY ARTERIES. LONGER AND OVERLAPPING STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. BASED ON THE LACK OF PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED STENT FRACTURE; HOWEVER, CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED TWO OVERLAPPING CYPHER STENTS IN THE RIGHT CORONARY ARTERY. THREE AND A HALF YEARS AFTER THE INDEX PROCEDURE, THE PATIENT CAME IN FOR ADDITIONAL TREATMENT AND THE PHYSICIAN FOUND STENT FRACTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R