BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2922840 · Received January 18, 2013

    Report

    Report Number
    2134265-2013-00126
    Event Type
    Death
    Date Received
    January 18, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - 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

    UPN CORRECTED FROM H7493911312300 TO UNK717. CATALOG/MODEL # CORRECTED FROM 39113-1230 TO UNKNOWN. PMA# OR 510K# CORRECTED FROM P110010 TO SIMILAR. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. 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

    IT WAS FURTHER REPORTED THAT FOLLOWING THE PLACEMENT OF THE 2.25X12MM PROMUS ELEMENT PLUS STENT, PLAQUE SHIFT OCCURRED. THE AREA OF PLAQUE SHIFT WAS TREATED USING THE 3.0X12MM PROMUS ELEMENT PLUS STENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR ID # 2134265-2013-00124. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, PATIENT DEATH OCCURRED. THE 2.25X10MM, 99% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE 1ST DIAGONAL. THE LESION WAS DIRECT STENTED WITH 2.25X12MM PROMUS ELEMENT PLUS AND 3.0X12MM PROMUS ELEMENT STENTS, RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED CHEST PAIN. FOUR DAYS POST INDEX PROCEDURE THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. NINE DAYS POST INDEX PROCEDURE THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT FOLLOWING THE PLACEMENT OF THE 2.25X12MM PROMUS ELEMENT PLUS STENT, PLAQUE SHIFT OCCURRED. THE AREA OF PLAQUE SHIFT WAS TREATED USING THE 3.0X12MM PROMUS ELEMENT PLUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28165 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717 15351810

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death