BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1983814 · Received February 10, 2011

    Report

    Report Number
    3003742446-2011-00062
    Event Type
    Injury
    Date Received
    February 10, 2011
    Report Date
    January 14, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THE EXACT EVENT DATE IS UNKNOWN BUT OCCURRED IN 2009 AND 2011. PLEASE NOTE THAT THE ADDRESS OF THE REPORTER (PATIENT) IS UNKNOWN AS IT WAS NOT PROVIDED WHEN THE EVENT WAS REPORTED TO THE MEDICAL AFFAIRS DEPARTMENT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THE PATIENT DEVELOPED CORONARY RESTENOSIS. THE REPORT RECEIVED FROM THE MEDICAL AFFAIRS DEPT. STATES THAT A FEMALE PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY CALLED TO INQUIRE ABOUT MEDICAL INFORMATION REGARDING CHROMIUM COBALT STENTS AND ADDITIONALLY REPORTED AN ADVERSE EVENT. THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN VESSEL IN 2006. IN 2009, SHE UNDERWENT BYPASS SURGERY AND JUST RECENTLY UNDERWENT TESTS THAT REVEALED A BLOCKAGE IN AN UNSPECIFIED VESSEL OF THE HEART. THE PATIENT UNDERWENT PERCUTANEOUS INTERVENTION (PCI) WITH STENT PLACEMENT. THE PATIENT WAS UNSURE AS TO WHAT VESSEL WAS TREATED OR WHAT BRAND STENT WAS PLACED. A FOLLOW UP PHONE CALL WAS MADE TO THE PATIENT AND SHE INFORMED ME THAT HER CARDIOLOGIST HAD READ THE RESULTS OF HER TESTS AND THERE WAS NO MENTION OF A PROBLEM WITH THE IMPLANTED CYPHER STENTS. THE RESULTS HAVE BEEN SENT TO A HOSPITAL IN BOSTON FOR REVIEW. IT IS UNKNOWN IF THE RESTENOSIS WAS WITHIN OR ADJACENT TO THE IMPLANTED CYPHER STENT; HOWEVER, WITHOUT FURTHER INFORMATION TO THE CONTRARY THIS EVENT WILL BE CAPTURED AS A COMPLAINT. THE CYPHER STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS 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. IN THIS CASE, THE VERY LIMITED INFORMATION DOES NOT ALLOW FOR A CONCLUSION TO BE DRAWN BETWEEN THE IMPLANTED DEVICE AND POSSIBLE CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THIS PATIENT REPORTED A POSSIBLE RESTENOSIS OF A CYPHER STENT. THE REPORT RECEIVED FROM THE MEDICAL AFFAIRS DEPT STATES THAT A FEMALE PATIENT CALLED TO INQUIRE ABOUT MEDICAL INFORMATION REGARDING CHROMIUM COBALT STENTS AND ADDITIONALLY REPORTED AN ADVERSE EVENT. THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN VESSEL IN 2006. IN 2009, SHE UNDERWENT BYPASS SURGERY AND JUST RECENTLY UNDERWENT TESTS THAT REVEALED A BLOCKAGE IN AN UNSPECIFIED VESSEL OF THE HEART. THE PATIENT UNDERWENT PERCUTANEOUS INTERVENTION (PCI) WITH STENT PLACEMENT. THE PATIENT WAS UNSURE AS TO WHAT VESSEL WAS TREATED OR WHAT BRAND STENT WAS PLACED. THE EVENT REMAINS ONGOING. THE ATTEMPT TO GAIN ADDITIONAL INFORMATION WAS REFUSED.

    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 Hospitalization| L| R