BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2120560 · Received June 10, 2011

    Report

    Report Number
    3003742446-2011-00299
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    January 18, 2006
    Report Date
    May 26, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ALTACE AND DIOVAN. PLEASE NOTE: THE CATALOG CODE ENTERED (UNKCYPHER), REPRESENTS AN UNKNOWN CYPHER STENT. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN AND WILL NOT BE AVAILABLE. INFORMATION RECEIVED FROM A PATIENT INDICATED THAT HE EXPERIENCED RESTENOSIS AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT HAD A HISTORY OF HYPERTENSION. THE PATIENT HAD A CYPHER STENT IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY FOR UNSPECIFIED REASONS ON (B)(6) 2005 AND WAS TOLD HIS DIAGONAL WAS 60% BLOCKED. ON (B)(6) 2006 THE PATIENT EXPERIENCED CHEST PAIN, ANGIOGRAPHY WAS PERFORMED AND REVEALED A 90% BLOCKAGE IN THE DIAGONAL. THE EVENT WAS TREATED WITH THE IMPLANT OF AN UNKNOWN CYPHER STENT. THE CHEST PAIN WAS RELIEVED FOR 1 1/2-2 YEARS, AND RESUMED U/U/U. TREATMENT WAS TO "BALLOON" THE DIAGONAL ON U/U/U. SINCE THAT TIME, HE REPORTED HAVING TO BE "BALLOONED" TWO MORE TIMES DUE TO SCAR TISSUE. HE ALSO HAS BEEN DIAGNOSED WITH DIABETES U/U/U. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE PATIENT INDICATED THAT HE HAD TWO 2.5 MM CYPHER STENTS PLACED IN THE "DIAGONAL BRANCH", BUT WAS NOT ABLE TO PROVIDE ANY MORE INFORMATION REGARDING THE STENTS. NO FURTHER INFORMATION WAS PROVIDED AS CONSUMER WAS ONLY LOOKING TO SEE IF THE CYPHER STENT CAME IN A SMALLER SIZE. THE STERILE LOT NUMBERS FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE VERY LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT, ALTHOUGH HYPERTENSION CAN PLAY A ROLE IN THE PROGRESSION OF CORONARY ARTERY DISEASE. THERE DOES NOT APPEAR TO BE A MANUFACTURING OR DESIGN RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2011-00299 AND 3003742446-2011-00300.

    Description of Event or Problem · 1

    A CYPHER CONSUMER CALLED FOR MEDICAL INFORMATION AND ALSO REPORTED ADVERSE EVENTS. CONSUMER HAD A CYPHER STENT IMPLANTED IN THE LAD FOR UNSPECIFIED REASONS ON (B)(6) 2005 AND WAS TOLD THAT HIS DIAGONAL WAS 60% BLOCKED. HE REPORTED HAVING CHEST PAIN (B)(6) 2006 AND A CARDIAC CATHETERIZATION WAS PERFORMED WHICH SHOWED A 90% BLOCKAGE IN THE DIAGONAL, AND A CYPHER STENT WAS IMPLANTED AS TREATMENT. IT IS UNKNOWN IF HE WAS HOSPITALIZED OVERNIGHT. CHEST PAIN WAS RELIEVED FOR 1 1/2-2 YEARS, AND RESUMED U/U/U. TREATMENT WAS TO " BALLOON" THE DIAGONAL U/U/U. SINCE THAT TIME, HE REPORTED HAVING TO BE " BALLOONED" TWO MORE TIMES DUE TO SCAR TISSUE. HE ALSO HAS BEEN DIAGNOSED WITH DIABETES U/U/U. NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER WHO CLARIFIED THAT HE HAD TWO 2.5 MM CYPHER STENTS PLACED IN THE "DIAGONAL BRANCH." NO FURTHER INFORMATION WAS PROVIDED AS CONSUMER WAS ONLY LOOKING TO SEE IF THE CYPHER STENT CAME IN A SMALLER SIZE.

    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) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R