BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3143300 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03461
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    May 21, 2013
    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. RELEVANT TESTS/LABORATORY DATA: (B)(6) 2013: TROPONIN I=2.699 NG/ML, UPPER REFERENCE LIMIT 0.05; (B)(6) 2013 (00:47): CK=32 U/L, NORMAL UPPER LIMIT 174; (B)(6) 2013 (12:41): CK=33 U/L, NORMAL UPPER LIMIT 174; (B)(6) 2013 (23:17): CK=43 U/L, NORMAL UPPER LIMIT 174; (B)(6) 2013 (00:47, 12:41): CK-MB=0.5 NG/ML, NORMAL UPPER LIMIT 4; (B)(6) 2013 (23:17): CK-MB=0.6 NG/ML, NORMAL UPPER LIMIT 4; (B)(6) 2013 (00:47): TROPONIN I=0.713 NG/ML, UPPER REFERENCE LIMIT 0.05; (B)(6) 2013 (12:41): TROPONIN I=0.397 NG/ML, UPPER REFERENCE LIMIT 0.05; (B)(6) 2013 (23:17): TROPONIN I=0.36 NG/ML, UPPER REFERENCE LIMIT 0.05; (B)(6) 2013: CK=44 U/L, NORMAL UPPER LIMIT 174; (B)(6) 2013: CK-MB=0.9 NG/ML, NORMAL UPPER LIMIT 4; (B)(6) 2013: TROPONIN I=0.33 NG/ML, UPPER REFERENCE LIMIT 0.05. CONCOMITANT MEDICAL PRODUCTS: STENT: FOUR XIENCE PRIME STENTS (2.25X12, 2.5X18, 3.0X18, 3.5X18) THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND ISCHEMIA ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH A SINGLE EPISODE OF ANGINA APPROXIMATELY TWO WEEKS AFTER THE INDEX CORONARY STENTING PROCEDURE WITH TWO XIENCE PRIME (2.25X23, 2.25X12) STENTS IN THE RIGHT CORONARY ARTERY (RCA), ONE XIENCE PRIME IN THE LEFT CIRCUMFLEX CORONARY ARTERY, AND TWO XIENCE PRIME STENTS IN THE LEFT MAIN CORONARY ARTERY. THE CHEST PAIN RESOLVED WITH SUBLINGUAL NITROGLYCERIN. THERE WERE NO ABNORMALITIES IN THE ELECTROCARDIOGRAM AND NO INCREASE IN CARDIAC BIOMARKERS. THE STRESS TEST WAS NEGATIVE, BUT THERE WAS A MINIMAL TERRITORY WITH ISCHEMIA. LOSARTAN, A CARDIOVASCULAR MEDICATION, WAS ADDED TO THE PATIENT'S MEDICAL REGIMEN. THE ANGINA DID NOT RETURN AND THE PATIENT WAS DISCHARGED SIX DAYS AFTER ADMISSION. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244427 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2073041

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R