BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2172039 · Received July 22, 2011

    Report

    Report Number
    2024168-2011-05086
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    February 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED MYOCARDIAL INFARCTION, PULMONARY EDEMA, RENAL FAILURE, STENOSIS AND ISCHEMIA ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THIRTEEN MONTHS POST STENTING PROCEDURE IN THE RIGHT POSTERIOR DESCENDING ARTERY WITH ONE XIENCE V 3.0 X 15 STENT, THE PATIENT WAS HOSPITALIZED WITH SHORTNESS OF BREATH, ELEVATED TROPONIN LEVELS, ACUTE SYSTOLIC HEART FAILURE, RESPIRATURE FAILURE WITH PULMONARY EDEMA. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH A NON Q-WAVE MYOCARDIAL INFARCTION WITH SILENT ISCHEMIA. TREATMENT INCLUDED NITROGLYCERIN, LOVENOX, DIURETIC THERAPY AND ON (B)(6) 2011 UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE TARGET VESSEL, NON-TARGET LESION WITH A XIENCE V 3.5 X 15 STENT. THE PATIENT DEVELOPED ACUTE RENAL FAILURE/ACUTE KIDNEY INJURY WITH A CREATINE INCREASED TO 1.9, THIS WAS MONITORED. THE PATIENT'S SYMPTOMS IMPROVED AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9100961

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R| S