BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4130414 · Received September 30, 2014

    Report

    Report Number
    2024168-2014-06330
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RELEVANT TESTS: (B)(6) 2014 (19:45): CK-MB=28.9 NG/ML, NORMAL UPPER LIMIT 5.0; (B)(6) 2014 (19:45): TROPONIN I=1.43 NG/ML, UPPER REFERENCE LIMIT 0.01; (B)(6) 2014: CK=486 U/L, NORMAL UPPER LIMIT 168; (B)(6) 2014: CK-MB=38.6 NG/ML, NORMAL UPPER LIMIT 5.0; (B)(6) 2014: TROPONIN I=5.33 NG/ML, UPPER REFERENCE LIMIT 0.01. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION AND OCCLUSION ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 3.0 X 18 MM XIENCE XPEDITION STENT IN THE PROXIMAL CIRCUMFLEX ARTERY. DURING THE PROCEDURE, A SMALL SIDE BRANCH WAS OCCLUDED. POST PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND CARDIAC ENZYMES WERE ELEVATED. THE PATIENT WAS NOTED TO HAVE A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) SECONDARY TO THE SIDE BRANCH OCCLUSION. MEDICATION WAS ADMINISTERED AS TREATMENT; HOWEVER, NO INTERVENTION WAS PERFORMED AS TREATMENT FOR THE SIDE BRANCH OCCLUSION. THE PATIENT CONDITION RESOLVED (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608856 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3100341

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention| S OTHER: ASPIRIN, CLOPIDOGREL