BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4933046 · Received July 22, 2015

    Report

    Report Number
    3003742446-2015-00042
    Event Type
    Injury
    Date Received
    July 22, 2015
    Report Date
    July 9, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PLAVIX (75MG/DAILY) (2003 - ONG). ATENOLOL (25MG/DAILY) (2003 - ONG). ASPIRIN (81MG/DAILY) (2003 - ONG). ZETIA (2003 - ONG). COMPLAINT CONCLUSION: THERE WAS NO STERILE LOT NUMBER PROVIDED AND THE DEVICE WAS NOT RETURNED, THEREFORE NO DHR REVIEW WILL BE PERFORMED AND NO PRODUCT ANALYSIS WILL BE COMPLETED. THIS PATIENT IS AT RISK FOR PROGRESSION OF CORONARY ARTERY DISEASE BASED ON THEIR MEDICAL HISTORY WHICH INCLUDED PREVIOUS SMOKING. RESTENOSIS IS ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. RESTENOSIS IS A WELL-DOCUMENTED POTENTIAL COMPLICATION OF STENT PLACEMENT IS SUBSEQUENT INTIMAL HYPERPLASIA AND OCCLUSION. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS, THEREFORE NO CORRECTIVE ACTION IS NEEDED.

    Description of Event or Problem · 1

    A CYPHER PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON (B)(6) 2004 PATIENT HAD A CYPHER STENT IMPLANTED IN AN UNSPECIFIED VESSEL FOR SEVERE CHEST PAIN DURING A TREADMILL TEST (RESULTS NOT OBTAINED) AFTER HAVING BURNING IN CHEST AND LOSS OF BREATH ON EXERTION. PATIENT WAS DISCHARGED HOME THE NEXT DAY, (B)(6) 2004. BEGINNING ON (B)(6) 2004 PATIENT EXPERIENCED AN UNKNOWN EVENT, MAYBE DISCOMFORT. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2004 AND A CYPHER STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL. PATIENT WAS DISCHARGED HOME THE NEXT DAY, (B)(6) 2004. PATIENT REPORTED AT TIME OF CALL HE WAS IN THE PROCESS OF GATHERING SAFETY INFORMATION TO HAVE THE MRI SCHEDULED AND PERFORMED. NO ADDITIONAL INFORMATION OBTAINED AT TIME OF CALL INCLUDING LOT NUMBER, PATIENT'S DATE OF BIRTH, AGE AT TIME OF EVENT, HEIGHT AND WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475655 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention