BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4303059 · Received December 8, 2014

    Report

    Report Number
    2024168-2014-07991
    Event Type
    Injury
    Date Received
    December 8, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 13, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ON (B)(6) 2014 (14:20): CREATINE KINASE-MYOCARDIAL BAND (CK-MB)=0.6 NG/ML, NORMAL UPPER LIMIT 5.0. ON (B)(6) 2014 (23:30): CK=227 U/L, NORMAL UPPER LIMIT 200. ON (B)(6) 2014 (23:30): CK-MB=20 NG/ML, NORMAL UPPER LIMIT 5.0. ON (B)(6) 2014 (09:55): CK=551 U/L, NORMAL UPPER LIMIT 200. ON (B)(6) 2014 (09:55): CK-MB=36.9 NG/ML, NORMAL UPPER LIMIT 5.0. ON (B)(6) 2014 (05:51): CK=460 U/L, NORMAL UPPER LIMIT 200. ON (B)(6) 2014 (05:51): CK-MB=38.6 NG/ML, NORMAL UPPER LIMIT 5.0. ON (B)(6) 2014 (05:51): TROPONIN I=7.56 NG/ML, NORMAL UPPER LIMIT 0.01. ON (B)(6) 2014 (12:44): CK=504 U/L, NORMAL UPPER LIMIT 200. ON (B)(6) 2014 (12:44): CK-MB=30.0 NG/ML, NORMAL UPPER LIMIT 5.0. ON (B)(6) 2014 (12:44): TROPONIN I=10.44 NG/ML, NORMAL UPPER LIMIT 0.01. ON (B)(6) 2014 (18:55): CK=458 U/L, NORMAL UPPER LIMIT 200. ON (B)(6) 2014 (18:55): CK-MB=18.1 NG/ML, NORMAL UPPER LIMIT 5.0. ON (B)(6) 2014 (18:55): TROPONIN=10.44 NG/ML, NORMAL UPPER LIMIT 0.01. ON (B)(6) 2014 (05:16): CK=277 U/L, NORMAL UPPER LIMIT 200. ON (B)(6) 2014 (05:16): CK-MB=7.7 NG/ML, NORMAL UPPER LIMIT 5.0. ON (B)(6) 2014 (05:16): TROPONIN=6.78 NG/ML, NORMAL UPPER LIMIT 0.01. CONCOMITANT MEDICAL PRODUCTS: SPRINTER LEGEND 2.5X10 BALLOON DILATATION CATHETER, XIENCE XPEDITION STENT (3.5X12, 3.0X23), ASPIRIN, TICAGRELOR. 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. MYOCARDIAL INFARCTION IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS 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 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 15 MM XIENCE XPEDITION STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, A 3.5 X 12 MM XIENCE XPEDITION STENT IN THE PROXIMAL LAD AND 3.0 X 23 MM XIENCE XPEDITION STENT IN THE RAMUS ARTERY. DURING IMPLANTATION OF THE 3.0 X 15 MM XIENCE XPEDITION (MID LAD), THE DIAGONAL ARTERY WAS INITIALLY JAILED, BUT BY THE END OF THE PROCEDURE WAS NOTED TO BE RECONSTITUTING. POST PROCEDURE, THE PATIENT'S CARDIAC ENZYMES WERE ELEVATED AND ELECTROCARDIOGRAM NOTED NON-ST ELEVATION MYOCARDIAL INFARCTION (MI). IT WAS THOUGHT THAT THE ENZYME ELEVATION AND MI WERE RELATED TO THE JAILED DIAGONAL ARTERY. NO TREATMENT WAS PROVIDED AND THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790218 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3111941

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability