BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1820346 · Received August 30, 2010

    Report

    Report Number
    3003742446-2010-00310
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    November 25, 2009
    Report Date
    August 3, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    CONSUMER HAD A CYPHER STENT IMPLANTED IN "THE DIAGONAL OFF THE MAIN ARTERY" ON (B)(6) 2009. SHE REPORTED THAT THE IMPLANTING PHYSICIAN STATED THAT IT WAS A "BAD PLACE TO PUT THE STENT," AND THAT HE PUNCTURED THE MAIN ARTERY OF HER HEART DURING THE PROCEDURE. THIS REQUIRED AN ADDITIONAL 3 DAYS IN THE HOSPITAL. FOUR DAYS AFTER PROCEDURE (B)(6) 2009, SHE EXPERIENCED A WEIRD FEELING IN HER HEAD, DESCRIBED AS A WEIGHTED PULLING SENSATION FROM THE BACK OF THE NECK, ACROSS HER SHOULDERS AND DOWN HER BACK. SHE ALSO HAD A WEIGHTED FEELING IN HER LEGS, WAS NAUSEATED, AND COULD NOT THINK PROPERLY. CONSUMER SAW PHYSICIAN WHO TOLD HER TO KEEP TAKING PLAVIX. NO OTHER TESTING OR TREATMENT REPORTED. IN (B)(6) 2010, SHE REPORTED NOT BEING ABLE TO GET HER HEAD CLEAR AND WORSENED WEIGHTED FEELING. SHE VISITED HER PHYSICIAN AGAIN, AND WAS TOLD TO "GO OFF PLAVIX." AFTER 5 DAYS, WHEN CONDITION REMAINED UNCHANGED, SHE WAS TOLD BY HER PHYSICIAN TO GO BACK ON PLAVIX. NO OTHER TESTING PERFORMED OR TREATMENT OFFERED. IN (B)(6) 2010 SHE WENT TO ANOTHER FACILITY UNDER THE CARE OF A DIFFERENT PHYSICIAN, WHERE AN EKG WAS PERFORMED AND WAS SAID TO BE ABNORMAL. ON (B)(6) 2010, CONSUMER HAD ANOTHER CARDIAC CATHETERIZATION (SCHEDULED) WHICH SHOWED THAT "THE STENT WAS HANGING INTO THE MAIN ARTERY" AND THERE WAS 80% BLOCKAGE OF THE MAIN ARTERY. TREATMENT WAS TO "CRUSH THE CYPHER STENT AND GET IT OUT OF THE WAY" AND IMPLANT A XIENCE STENT IN THE MAIN ARTERY. THIS REQUIRED A ONE NIGHT HOSPITAL STAY. THE EVENTS OF WEIGHTED SENSATIONS IN HER HEAD, SHOULDERS, BACK AND LEGS, AS WELL AS COGNITIVE DIFFICULTY RESOLVED (B)(6) 2010. ON (B)(6) 2010, CONSUMER HAD A "HEART ABLATION" FOR UNSPECIFIED REASONS. ON (B)(6) 2010, SHE EXPERIENCED NAUSEA AND THE RECURRENCE OF THE WEIGHTED SENSATIONS IN HEAD,SHOULDERS,BACK AND LEGS, AS WELL AS COGNITIVE DIFFICULTY. ON (B)(6) 2010 SHE WENT TO THE ER WHERE AN MRI WAS PERFORMED ON HER NECK AND HEAD WHICH SHOWED "NO BLOCKAGE."

    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 15032855

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening PLAVIX AND SYNTHROID