BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3180114 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04306
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) STUDY. SAME CASE AS 2134265-2013-04307. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN. IN (B)(6) 2013, THE SUBJECT PRESENTED WITH MI WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IB). CARDIAC CATHETERIZATION WAS RECOMMENDED. TARGET LESION #1 WAS LOCATED IN THE MID RCA WITH 95% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00 X 20 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE TARGET LESION #2 WAS LOCATED IN THE MID LAD WITH 75% STENOSIS AND WAS 23 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 X 28 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. IN ADDITION A NON-TARGET LESION LOCATED IN PROXIMAL LAD, WAS TREATED WITH PLACEMENT OF A 3.00 X 12 MM DRUG ELUTING STENT. THE SUBJECT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. TWENTY DAYS AFTER, CARDIAC CHEST PAIN OCCURRED. THE SUBJECT WAS TREATED WITH MEDICATION. A FUTURE CORONARY ARTERY BYPASS PROCEDURE WAS PLANNED.

    Description of Event or Problem · 1

    IT WAS FURTHER DISCOVERED THAT MDR ID: 2134265-2013-04306 WAS REPORTED AS DUPLICATE REPORT TO MDR ID: 2134265-2013-04114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279929 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420300 15615513

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention