BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2830220 · Received November 13, 2012

    Report

    Report Number
    2024168-2012-07147
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 19, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ADD'L DEVICES/CONCOMITANT PRODUCTS: STENT: XIENCE PRIME 4.0X23, 3.0X18, 2.5X23; OTHER: UNFRACTIONATED HEPARIN, ABCIXIMAB, LOW OSMOMOLAR CONTRAST, ASPIRIN, PRASUGREL VESSEL CLOSURE: ANGIOSEAL. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND ANGINA 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).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, ADDITIONAL INFORMATION RECEIVED INDICATES THE SIZE OF THE XIENCE PRIME STENT IN THE OBTUSE MARGINAL CORONARY ARTERY WAS 2.5 IN DIAMETER. ADDITIONALLY, ON (B)(6) 2012, THE PATIENT HAD ANGINA THAT WAS TREATED WITH METOPROLOL. THE PHYSICIAN INDICATED THE ANGINA IS UNLIKELY RELATED TO THE XIENCE PRIME STENT, BUT POSSIBLY RELATED TO THE STENTING PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST PROCEDURE, AFTER THE IMPLANTATION OF TWO XIENCE PRIME STENTS (4.0X23, 3.0X18) IN THE LEFT MAIN CORONARY ARTERY, ONE XIENCE PRIME STENT (2.25X12) IN THE OBTUSE MARGINAL CORONARY ARTERY, AND ONE XIENCE PRIME STENT (2.5X23) IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY, THE PATIENT HAD A MYOCARDIAL INFARCTION WITH ASSOCIATED CHEST PAIN LASTING MORE THAN 10 MINUTES AND NEW BIOMARKER ELEVATION. NITROGLYCERIN WAS ADMINISTERED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PHYSICIAN INDICATED THAT THIS EVENT IS UNLIKELY RELATED TO THE XIENCE STENT, BUT PROBABLY RELATED TO THE STENTING PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2070941

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R| S