BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2853139 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07583
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMMITANT DEVICES: STENT: XIENCE PRIME 3.0 X 18; OTHER: ASPIRIN, CLOPIDOGREL. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILED ON (B)(6) 2012, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATES THAT THE PATIENT UNDERWENT DIAGNOSTIC CORONARY ANGIOGRAPHY ON (B)(6) 2012. THE ANGIOGRAPHY NOTED THERE WAS GOOD FUNCTION IN THE STENT IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE STENT IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (RCA); HOWEVER, THERE WAS AN AREA OF SIGNIFICANT STENOSIS IN THE PROXIMAL RCA WHICH HAD BEEN PREVIOUSLY DEEMED AS NOT SIGNIFICANT. ON (B)(6) 2012, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION TO TREAT THE AREA OF STENOSIS IN THE PROXIMAL RCA. THE PATIENT'S CHEST PAIN RESOLVED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT EXPERIENCED ADDITIONAL EPISODES OF ANGINA. NO TREATMENT WAS PROVIDED AND THE ANGINA RESOLVED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A STENTING PROCEDURE ON (B)(6) 2012 WITH PLACEMENT OF A 3.0 X 18 MM XIENCE PRIME STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS AND A 3.0 X 18 MM XIENCE PRIME IN THE DISTAL RIGHT CORONARY ARTERY WITH 90% STENOSIS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT EXPERIENCED CHEST PAIN, CLASSIFIED AS UNSTABLE ANGINA, AND WAS REHOSPITALIZED. MEDICATION WAS ADMINISTERED. ELECTROCARDIOGRAM PERFORMED ON (B)(6) 2012 NOTED ST CHANGES. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON (B)(6) 2012 AT A NON-TARGET LESION IN THE TARGET VESSEL. THE PATIENT'S CHEST PAIN CONTINUES. PATIENT IS TO UNDERGO AN ADDITIONAL REVASCULARIZATION PROCEDURE AT A LATER DATE. 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 2050941

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R