BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1973129 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00525
    Event Type
    Death
    Date Received
    January 28, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 19, 2011
    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): PATIENT SELECTION. DILATATION CATHETER: 2.0X15 APEX; GUIDE WIRE: ROUTE; GUIDE CATH: MACH1 6F FL3.5 THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH AND VENTRICULAR FIBRILLATION ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. IT WAS REPORTED THE XIENCE V WAS USED TO TREAT AN ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT. IT SHOULD BE NOTED THE IFU STATES: THE XIENCE V IS CONTRAINDICATED FOR USE IN PATIENTS WHO HAD RECENT AMI OR WHO HAVE NOT NORMALIZED THE CARDIAC ENZYME LEVELS AFTER AMI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ACUTE MYOCARDIAL INFARCT (AMI) PATIENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN WHICH CONTINUED FOR 5 DAYS. ON (B)(6) 2011, THE CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED A CHRONIC TOTAL OCCLUSION IN THE MID LEFT ANTERIOR DESCENDING ARTERY, WITH A 0 TIMI FLOW. THERE WAS NO TORTUOSITY AND NO CALCIFICATION. THE VESSEL DIAMETER PROXIMAL TO THE TARGET LESION WAS 3.5 MM, BUT THE DIAMETER OF THE DISTAL LESION WAS ONLY 2.0 MM. THE TARGET VESSEL LENGTH WAS 15 MM. THE PHYSICIAN THOUGHT THAT RE-PERFUSION AND RE-OCCLUSION WERE REPEATED BETWEEN (B)(6) 2010 AND (B)(6) 2011. AFTER PRE-DILATING WITH A 2.0 X 15 NON-ABBOTT BALLOON, THE 2.5 X 18 XIENCE V STENT WAS IMPLANTED AT 8 ATMOSPHERES (ATM). POST-DILATATION WAS PERFORMED AT 12 ATM. TIMI III FLOW WAS ACHIEVED. POST-PROCEDURE, THE PATIENT EXPERIENCED CONTINUING VENTRICULAR FIBRILLATION (VF) AND REMAINED HOSPITALIZED. ON (B)(6) 2011, THE PATIENT DIED. THE PHYSICIAN COMMENTED THAT HE WAS NOT SURE OF THE REASON FOR THE PATIENT'S DEATH, BUT HE THOUGHT/GUESSED THAT THE IMPLANTED XIENCE V WAS NOT OCCLUDED. IN ADDITION, HE THOUGHT/GUESSED THAT THIS CASE WAS NOT BY STENT THROMBOSIS, BUT BY VF. NO ADDITIONAL INFORMATION WAS 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 0061441

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death