BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2876203 · Received December 17, 2012

    Report

    Report Number
    2024168-2012-08016
    Event Type
    Death
    Date Received
    December 17, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 (IFU), ARE KNOWN ADVERSE PATIENT EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF CARDIAC ARREST, DEATH, FEVER, RASH, THROMBOSIS, ARRHYTHMIAS (VENTRICULAR FIBRILLATION, VENTRICULAR TACHYCARDIA) AND HYPERSENSITIVITY (ALLERGIC REACTION), AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) 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. THE ADDITIONAL RX XIENCE PRIME INDICATED BEING FILED UNDER A SEPARATE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A XIENCE PRIME STENT WAS IMPLANTED ON (B)(6) 2012, IN THE RIGHT CORONARY ARTERY (RCA) ARTERY. IT WAS NOTED THAT ON (B)(6) 2012, A NON-ABBOTT STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. ON (B)(6) 2012, THE SUBJECT EXPERIENCED ELEVATED CPK AND STENT THROMBOSIS OF THE RCA. THROMBUS ASPIRATION WAS PERFORMED; HOWEVER, ON (B)(6) 2012, THE SUBJECT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT WAS TRANSFERRED EMERGENTLY ON (B)(6) 2012, TO THE HOSPITAL SUFFERING AN ACUTE MYOCARDIAL INFARCTION (AMI) AND RECEIVED TWO 3.0 X 15 MM XIENCE PRIME STENTS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). WHILE STILL HOSPITALIZED ON (B)(6) 2012, THE SUBJECT RECEIVED A 3.5 X 18 MM NON-ABBOTT STENT AND A 3.0 X 22 MM NON-ABBOTT STENT IN THE MID TO PROXIMAL LAD. ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) WERE PERFORMED AND THE STENT IMPLANTS WERE CONFIRMED TO BE FULLY EXPANDED AND NO ANOMALY WAS NOTED. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED A RASH AND IT WAS SUSPECTED TO BE AN ALLERGIC REACTION TO THE CONTRAST MEDIA. ANTIBIOTICS WERE ADMINISTERED AS THE SUBJECT ALSO HAD AN EXISTING UNRELATED FEVER PRIOR TO THE PROCEDURE. ON (B)(6) 2012, THE SUBJECT HAD VENTRICULAR TACHYCARDIA (VT) FOLLOWED BY ATRIAL FIBRILLATION (AF) AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. ANGIOGRAPHY OF THE LAD SHOWED THROMBOTIC OCCLUSION FROM THE PROXIMAL PORTION OF THE NON-ABBOTT STENT. THROMBUS WAS ASPIRATED AND ALTHOUGH SLIGHT THROMBOSIS WAS NOTED, BLOOD FLOW WAS RESTORED. ANGIOGRAPHY WAS NOT PERFORMED FOR THE RCA; CPK BLOOD TESTS VALUES WERE NOT AVAILABLE AS THEY WERE NOT PERFORMED. DESPITE CONTINUOUS ATTEMPTS WITH CPR, THE SUBJECTS CARDIAC FUNCTION DID NOT IMPROVE AND THE SUBJECT EXPIRED ON (B)(6) 2012. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death STENT: RESOLUTE INTEGRITY