BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1841971 · Received September 23, 2010

    Report

    Report Number
    3003742446-2010-00333
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 24, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2010-00334THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 3003742446-2010-00334 INFORMATION RECEIVED FROM A PATIENT VIA MEDICAL AFFAIRS INDICATED THAT THE PATIENT EXPERIENCED POSSIBLE RESTENOSIS, CHEST PAIN AND DYSPNEA AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY CONSISTS OF NO KNOWN DRUG ALLERGIES, CORONARY ARTERY DISEASE, HYPERTENSION, GOUT, HYPOTHYROIDISM AND A MORTON'S NEUROMA. THE PATIENT HAD A CYPHER STENT IMPLANTED IN THE FIRST DIAGONAL ARTERY FOR AN UNKNOWN REASON. SIX DAYS LATER, THE PATIENT HAD A SECOND CYPHER STENT PLACED IN THE FIRST DIAGONAL FOR AN UNKNOWN REASON. ONE MONTH LATER, THE PATIENT HAD A XIENCE STENT IMPLANTED IN AN UNKNOWN VESSEL FOR AN UNKNOWN REASON. TWO MONTHS LATER, THE PATIENT HAD A THIRD CYPHER STENT PLACED IN AN UNKNOWN VESSEL FOR AN UNKNOWN REASON. THE FOLLOWING MONTH, THE PATIENT EXPERIENCED CHEST PAIN AND DIFFICULTY BREATHING. SHE WAS SEEN IN THE HOSPITAL ON AN OUTPATIENT BASIS, HAD A CARDIAC CATHETERIZATION AND WAS DISCHARGED HOME. NO TREATMENT WAS REPORTED AND ALL EVENTS WERE RESOLVED. BECAUSE THE REASON FOR IMPLANTING THE OTHER TWO CYPHER STENTS IS UNKNOWN AND THE EXACT LOCATION IS UNKNOWN THESE EVENTS WILL BE CAPTURED AS RESTENOSIS. THE STERILE LOT NUMBERS FOR (B)(4) IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. THE DHR FOR (B)(4) PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. RESTENOSIS, CHEST PAIN AND DYSPNEA ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE PROGRESSION OF CORONARY ARTERY DISEASE. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CYPHER STENT PATIENT CALLED REQUESTING HYPERSENSITIVITY INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. THE PATIENT IS A (B)(6) FEMALE. ON (B)(6)2010, THE PATIENT HAD A CYPHER STENT PLACED IN THE FIRST DIAGONAL FOR AN UNKNOWN REASON. ON (B)(6)2010, THE PATIENT HAD A SECOND CYPHER STENT IMPLANTED IN THE FIRST DIAGONAL FOR AN UNKNOWN REASON. A MONTH LATER THE PATIENT HAD A XIENCE STENT PLACED IN AN UNKNOWN VESSEL FOR AN UNKNOWN REASON. TWO MONTHS LATER, THE PATIENT HAD A THIRD CYPHER STENT PLACED IN AN UNKNOWN VESSEL FOR AN UNKNOWN REASON. PATIENT REPORTED THAT HER "HAIR STARTED FALLING OUT" A COUPLE WEEKS AGO. PHYSICIAN WAS AWARE OF EVENT, NO TREATMENT REPORTED FOR THIS ONGOING EVENT. THE FOLLOWING MONTH, THE PATIENT EXPERIENCED CHEST PAIN AND DIFFICULTY BREATHING. SHE WAS SEEN IN THE HOSPITAL ON AN OUTPATIENT BASIS, HAD A CARDIAC CATHETERIZATION AND WAS DISCHARGED HOME. NO TREATMENT WAS REPORTED. ALL EVENTS WERE RESOLVED.

    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 74 YR Hospitalization| R PLAVIX, ASPIRIN, LIPITOR, LISINOPRIL