BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3864115 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03172
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    September 10, 2013
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-03170, 2134265-2014-03171, 2134265-2014-03173. (B)(4) STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) AND CHEST PAIN OCCURRED. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WAS PERFORMED. TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 100% STENOSIS AND WAS 70 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A TOTAL OF 4 OVERLAPPING PROMUS ELEMENT¿ PLUS STENTS (2.25 X 32 MM, 2.25 X 32 MM, 2.50 X 20 MM, AND 2.50 X 12 MM). FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION # 2 WAS A DE NOVO LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 60% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 12 MM PROMUS ELEMENT¿ PLUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO CHEST PAIN. FOURTEEN DAYS FROM THE ONSET OF SYMPTOMS, THE PATIENT WAS HOSPITALIZED. SUBSEQUENTLY, CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 90% ISR OF STUDY STENTS DEPLOYED IN MID PORTION OF LAD AND 30% ISR OF STUDY STENT IN LMCA. NO INTERVENTION WAS PERFORMED TO TREAT THE EVENT. THREE DAYS FROM ADMISSION, THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337737 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420250 0014959057

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization