BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3864147 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03168
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 7, 2014
    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: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-03165, 2134265-2014-03167, 2134265-2014-03169. (B)(4). 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) 2014, THE PATIENT PRESENTED WITH 2 DAY HISTORY OF CHEST PAIN AND THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. SUBSEQUENTLY, CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED LAD (TARGET VESSEL): 90% ISR OF STUDY STENTS DEPLOYED IN MID PORTION. THE PATIENT WAS TREATED WITH MEDICATIONS AND RECOMMENDED FOR REVASCULARIZATION OF THE LEFT CIRCUMFLEX (LCX). HOWEVER, PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS NOT PERFORMED DURING THE EVENT. FOUR 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
    337782 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420250 0014959057

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R