BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2880512 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08184
    Event Type
    Death
    Date Received
    December 19, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 CUSTOMER REPORTED THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE XIENCE PRIME, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND DEATH AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN TREATED WITH TWO XIENCE PRIME DRUG ELUTING STENTS AND ONE BIORESORBABLE VASCULAR SCAFFOLD (BVS). THE BVS WAS IMPLANTED TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 99% STENOSIS. PRE-DILATATION WAS PERFORMED WITH A NON-COMPLIANT BALLOON CATHETER AT 20 ATMOSPHERES (ATM) AND ANGIOSCHOOL IN THE LAD. THE INFLATATION OF THE BVS SCAFFOLD WAS PERFORMED IN INCREMENTS OF 2 ATM PER 5 SECONDS. THE INFLATION OF THE BVS SCAFFOLD WAS AT 16 ATM FOR MORE THAN 20 SECONDS. THE DEPLOYMENT PRESSURE WAS MAINTAINED FOR 30 SECONDS. NO POST-DILATATION WAS PERFORMED FOR THE BVS SCAFFOLD AS THERE WAS GOOD APPOSITION. THE XIENCE PRIME STENTS TREATED THE DISTAL LAD. THE PATIENT WAS IN THE HOSPITAL TWO WEEKS PRIOR TO BEING DISCHARGED AFTER THE PERCUTANEOUS CORONARY INTERVENTION AND IMPLANTATION OF THE TWO STENTS AND ONE SCAFFOLD. TWO DAYS LATER THE PATIENT WENT TO THE EMERGENCY ROOM FEELING DIZZY. AN ELECTROCARDIOGRAM (ECG) WAS TAKEN AT EMERGENCY ROOM. APPARENTLY THE PATIENT DIED TWO DAYS AFTER THE INITIAL HOSPITAL DISCHARGE. THE PHYSICIAN IS REPORTING THIS DEATH DUE TO THE ARC DEFINITIONS MATCHES WITH STENT THROMBOSIS. THE PHYSICIAN STRONGLY BELIEVES THAT THE DEATH WAS DUE TO THE PATIENT'S CONDITION OF HEALTH (EF< 15% IN THE TIME OF IMPLANT). THE ECG DID NOT SHOW ELECTRICAL CHANGES IN THE MOMENT OF THE WORSENING. NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1091541

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death STENT: XIENCE PRIME 2.5 X 18 OTHER: ABSORB BVS