BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2830070 · Received November 13, 2012

    Report

    Report Number
    3003742446-2012-00527
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ASPIRIN AND PLAVIX. PLEASE NOTE THAT THE EXACT EVENT DATE IS UNKNOWN AS IT WAS NOT OBTAINED FROM THE REPORTER. COMPLAINT CONCLUSION: AS REPORTED FROM THE (B)(6), THE PATIENT EXPERIENCED RESTENOSIS IN AN UNSPECIFIED VESSEL DIAGNOSED THROUGH UNSPECIFIED TESTS. THE PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENT. ON (B)(6) 2006, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN VESSEL DUE TO UNKNOWN REASONS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SOME BLOCKAGE OF AN UNSPECIFIED VESSEL DIAGNOSED BY UNSPECIFIED TESTS DESCRIBED AS THE CYPHER STENT WAS NOT AS EFFECTIVE TODAY AS IT WAS WHEN IT HAD BEEN IMPLANTED. ADDITIONAL INFORMATION INCLUDING; CONTACT INFORMATION, TREATMENT, OUTCOME, AND PHYSICIAN AWARENESS WAS REFUSED BY THE PATIENT. THERE WAS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    AS REPORTED FROM THE (B)(6), THE PATIENT EXPERIENCED A BLOCKAGE IN AN UNSPECIFIED VESSEL DIAGNOSED THROUGH UNSPECIFIED TESTS. THE PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENT. ON (B)(6) 2006, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN VESSEL DUE TO UNKNOWN REASONS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SOME BLOCKAGE OF AN UNSPECIFIED VESSEL DIAGNOSED BY UNSPECIFIED TESTS DESCRIBED AS THE CYPHER STENT WAS NOT AS EFFECTIVE TODAY AS IT WAS WHEN IT HAD BEEN IMPLANTED. ADDITIONAL INFORMATION INCLUDING; CONTACT INFORMATION, TREATMENT, OUTCOME, AND PHYSICIAN AWARENESS WAS REFUSED BY THE PATIENT.

    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