BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3980782 · Received August 5, 2014

    Report

    Report Number
    2134265-2014-04757
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIB. TO AE AND DESCRIBE EVENT OR PROBLEM-CORRECTED AND UPDATED RELEVANT TESTS/LAB DATA-UPDATED (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2014, THE PATIENT ALSO PRESENTED DUE TO CHEST PAIN WHILE WALKING AND WAS HOSPITALIZED ON THE SAME DAY. PATIENT'S ELECTROCARDIOGRAM (ECG) REVEALED LEFT AXIS DEVIATION AND ST-SEGMENT ABNORMALITY, WHICH WAS CONSIDERED ANTEROLATERAL ISCHEMIA. ALSO, CORONARY ANGIOGRAPHY WAS PERFORMED AND SHOWED A 90% IN-STENT RESTENOSIS (ISR) AT THE OSTIUM (DISTAL ANASTOMOSIS APPEARS INTACT) OF THE STUDY STENT IN LEFT INTERNAL MAMMARY ARTERY (LIMA) TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, NOT STENT THROMBOSIS AS WAS PREVIOUSLY REPORTED. ELEVEN DAYS FROM ADMISSION, THE PATIENT PRESENTED WITH SYMPTOMS OF MYOCARDIAL INFARCTION (MI). PATIENT'S CARDIAC ENZYME WAS ELEVATED (PEAK TROPONIN I = 3.68 NG/ML, ULN=0.08 NG/ML) REPEAT CORONARY ARTERY BYPASS GRAFT (REDO-CABG) IN BOTH TARGET VESSEL REVASCULARIZATION (TVR) AND NON-TVR VESSELS WAS PERFORMED TO TREAT THIS EVENT. ON AUGUST 2014, THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. ON (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS AN OSTIAL LESION LOCATED IN THE LEFT INTERNAL MAMMARY ARTERY (LIMA) TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 6MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 8MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2014, THE PATIENT PRESENTED DUE TO WORSENING OF CORONARY ARTERY DISEASE AND WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 99% STENT THROMBOSIS OF THE PREVIOUSLY PLACED STUDY STENT LOCATED IN THE LIMA TO MID LAD. ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED AND NO OTHER PROCEDURE WERE PERFORMED TO TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457480 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911408250 15373800

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R