BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 4223753 · Received November 4, 2014

    Report

    Report Number
    2134265-2014-06698
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    June 24, 2014
    Report Date
    October 13, 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. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-06699. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2013, THE PATIENT WAS PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) WITH 95 % STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 16 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0 %. THE TARGET LESION #2 WAS A DE NOVO LONG LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) EXTENDING TO DISTAL RCA WITH 80 % STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00 X 38 MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0 %. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2014, THE PATIENT WAS ADMITTED TO HOSPICE CARE AND EXPIRED 8-DAYS AFTER HOSPITALIZATION FOR PNEUMONIA. THE SITE BECAME AWARE OF THE PATIENT'S DEATH THROUGH AN ON-LINE OBITUARY AND THE CAUSE OF PATIENT'S DEATH IS UNKNOWN. ALSO, LAST CONTACT WITH THE PATIENT WAS ON (B)(6) 2014, DURING REQUIRED 1 YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705477 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911438400 15386922

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death