BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1352065 · Received March 25, 2009

    Report

    Report Number
    3003742446-2009-00054
    Event Type
    Injury
    Date Received
    March 25, 2009
    Date of Event
    March 15, 2005
    Report Date
    February 26, 2009
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS MEDWATCH REFLECTS TWO PRODUCTS WITH UNKNOWN CATALOG AND LOT NUMBERS. A PATIENT CALLED FOR INFORMATION AND ADDITIONALLY REPORTED AN ADVERSE EVENT. THE PATIENT WAS DIAGNOSED WITH TWO-VESSEL DISEASE. THE PATIENT'S MEDICAL HISTORY CONSISTS OF HIGH CHOLESTEROL, HYPERTENSION, OSTEOPOROSIS AND THYROIDECTOMY. THE PATIENT RECEIVED TWO UNKNOWN CYPHER STENTS DURING THE INDEX PROCEDURE IN THE LAD. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A "MILD HEART ATTACK". THERE WAS NO OTHER INJURY REPORTED. THE PHYSICIAN DECIDED TO TREAT THE SECOND LESION LOCATED IN THE RCA AT A LATER TIME FOR UNKNOWN REASONS. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE PATIENT DID NOT HAVE THE STENT INFORMATION CARD TO SUPPLY THE PRODUCT'S INFORMATION. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT THE LOT NUMBERS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENT. HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO IT.

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY IN 2005, THIS PATIENT HAD 2 CYPHER STENT PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY DUE TO "BLOCKAGES". DURING THE PROCEDURE, THE PATIENT EXPERIENCED A "MILD HEART ATTACK". ADDITIONAL "BLOCKAGE" WAS NOTED AT THAT TIME IN THE "RAD". IT WAS DECIDED, PER THE PHYSICIAN, TO PLACE MORE STENTS IN THE "RAD" AT A ALTER DATE. APPROXIMATELY ONE YEAR ALTER, IN 2006, THE PATIENT EXPERIENCED "PRESSURE AND SQUEEZING" IN HER CHEST. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS ADMITTED INTO THE HOSPITAL. THE PATIENT WAS TREATED WITH THE PLACEMENT OF TWO ADDITIONAL CYPHER STENTS IN THE "RAD". THE EVENT OF "PRESSURE AND SQUEEZING" RESOLVED. IN 2008, THE PATIENT ADDITIONALLY EXPERIENCED AN INCREASE IN HYPERTENSION AND WAS TREATED WITH LISINOPRIL. SHORTLY AFTER STARTING THE LISINOPRIL, THE PATIENT DEVELOPED A COUGH. THE PATIENT'S ALLERGIST STATED THAT SHE MOST LIKELY DEVELOPED AN ALLERGY TO THE LISINOPRIL. THE LISINOPRIL WAS DISCONTINUED AND DIOVAN WAS STARTED AND THE EVENT OF "COUGH" WAS RESOLVED. THE PATIENT HAS ONGOING ALLERGIES TO LISINOPRIL. THE PATIENT'S CURRENT MEDICATION TREATMENT INCLUDES; PLAVIX, TOPROL, FOSAMAX, LIPITOR AND SYNTHROID.

    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 72 YR Life Threatening