BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5073066 · Received September 12, 2015

    Report

    Report Number
    2024168-2015-05302
    Event Type
    Death
    Date Received
    September 12, 2015
    Date of Event
    March 9, 2015
    Report Date
    October 13, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THIS INCIDENT; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ARRHYTHMIA, DEATH/EXPIRED AND HYPOTENSION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. 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 ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, WITH PLACEMENT OF A 3.0 X 12 MM PROMUS STENT IN THE DISTAL CIRCUMFLEX ARTERY. ON (B)(6) 2015, THE PATIENT HAD AN EPISODE OF DYSPNEA AND WAS DIAGNOSED WITH HEART FAILURE. THE PATIENT WAS PRESCRIBED BED REST. ON (B)(6) 2015, THE PATIENT HAD A LOSS OF APPETITE AND DIFFICULTY SWALLOWING. ARRHYTHMIA WAS OBSERVED AND THE PATIENT WAS HYPOTENSIVE. INTRAVENOUS FLUIDS WERE ADMINISTERED. ON (B)(6) 2015, LACTIC ACIDOSIS WAS NOTED, DUE TO THE CARDIAC FAILURE AND SEPSIS. THE PHYSICIAN ADMITTED THE PATIENT AND MEDICATION WAS ADMINISTERED. AFTER HOSPITAL ADMISSION, THE PATIENT WAS NOTED TO BE PULSELESS AND EXPERIENCED VENTRICULAR TACHYARRHYTHMIA. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND THE PATIENT WAS REVIVED. SPONTANEOUS RESPIRATION BEGAN; HOWEVER, THE BLOOD PRESSURE GRADUALLY DECREASED. THE PATIENT EXPIRED ON (B)(6) 2015, OF CAUSES RELATED TO HEART FAILURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED WHICH INDICATED THAT THE IMPLANTED DEVICE IS A 3.0 X 12 MM XIENCE V STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604608 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9101441

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death