BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3230195 · Received July 16, 2013

    Report

    Report Number
    2024168-2013-04470
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RELEVANT TESTS: (B)(6) 2013 (08:35): TROPONIN I=NEGATIVE VALUE FOR MYOCARDIAL INFARCTION, UPPER REFERENCE LIMIT 0.05 NG/ML; (B)(6) 2013 (21:52): TROPONIN I=0.14 NG/ML, UPPER REFERENCE LIMIT 0.05; (B)(6) 2013: CK=61 IU/L, NORMAL UPPER LIMIT 181; (B)(6) 2013: CK-MB=6.3 NG/ML, NORMAL UPPER LIMIT 6.3; (B)(6) 2013: TROPONIN I=0.65 NG/ML, UPPER REFERENCE LIMIT 0.05. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE XIENCE V/XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 2.75 X 23 MM XIENCE V STENT IN THE PROXIMAL LEFT CIRCUMFLEX (CX) ARTERY AND PLACEMENT OF A 2.5 X 23 MM XIENCE V STENT IN THE DISTAL RIGHT CORONARY ARTERY (RCA). POST STENT DEPLOYMENT IN THE RCA, A HAZY AREA WAS NOTED AT THE DISTAL EDGE OF THE STENT AND A DISSECTION WAS NOTED. A 2.25 X 12 MM XIENCE NANO STENT WAS DEPLOYED TO TREAT THE DISSECTION. POST PROCEDURE, TROPONIN I LEVELS WERE ELEVATED. NO TREATMENT WAS PROVIDED; HOWEVER, NO MYOCARDIAL INFARCTION WAS DIAGNOSED. THE PATIENT CONDITION RESOLVED THE SAME DAY AND THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329785 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2052841

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention OTHER: CLOPIDOGREL, ASPIRIN