BEUDAMED
    FDA Adverse Event Death Summary report: N

    STENT CORONARY

    MDR report key: 4631986 · Received March 25, 2015

    Report

    Report Number
    9616099-2015-00133
    Event Type
    Death
    Date Received
    March 25, 2015
    Report Date
    March 9, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL AND FINAL COMBINATION REPORT FOR THIS COMPLAINT. COMPLAINT CONCLUSION: THE "BEST FRIEND" OF AN UNSPECIFIED STENT BRAND PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. PATIENT HAD AN UNSPECIFIED STENT (NOT SPECIFIED IF IT WAS A CORDIS PRODUCT) IMPLANTED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON ON U/U/U, BEFORE (B)(6) 2006. PATIENT BEGAN PLAVIX THERAPY, UNSPECIFIED DOSING REGIMEN, ON U/U/U AND "WAS TOLD BY HER CARDIOLOGIST TO TAKE IT FOR ONLY 3 MONTHS, WHICH SHE DID". PLAVIX WAS DISCONTINUED ON U/U/U. ON U/U/U PATIENT EXPERIENCED "CLOTS" WHICH RESULTED IN DEATH AND REPORTER STATED "HE KILLED HER" REFERRING TO THE DOCTOR WHO HAD DISCONTINUED THE PLAVIX. NO FURTHER INFORMATION COULD BE OBTAINED AS REPORTER ABRUPTLY DISCONNECTED THE CALL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AND INSTIGATE VESSEL REMODELING AROUND THE STENT, PRODUCING GAPS BETWEEN THE STENT AND THE VESSEL WALL. BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE "BEST FRIEND" OF AN UNSPECIFIED STENT BRAND PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. PATIENT HAD AN UNSPECIFIED STENT (NOT SPECIFIED IF IT WAS A CORDIS PRODUCT) IMPLANTED IN AN UNSPECIFIED VESSEL FOR AN UNSPECIFIED REASON ON U/U/U, BEFORE (B)(6) 2006. PATIENT BEGAN PLAVIX THERAPY, UNSPECIFIED DOSING REGIMEN, ON U/U/U AND "WAS TOLD BY HER CARDIOLOGIST TO TAKE IT FOR ONLY 3 MONTHS, WHICH SHE DID". PLAVIX WAS DISCONTINUED ON U/U/U. ON U/U/U PATIENT EXPERIENCED "CLOTS" WHICH RESULTED IN DEATH AND REPORTER STATED "HE KILLED HER" REFERRING TO THE DOCTOR WHO HAD DISCONTINUED THE PLAVIX. NO FURTHER INFORMATION COULD BE OBTAINED AS REPORTER ABRUPTLY DISCONNECTED THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201399 STENT CORONARY CORONARY SDS/STENTS MAF CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death