BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2993180 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01258
    Event Type
    Death
    Date Received
    March 7, 2013
    Date of Event
    October 26, 2012
    Report Date
    February 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A DEATH OCCURRED. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION(AMI) (ST-ELEVATION) AND WAS ADMITTED TO THE HOSPITAL. THE DE NOVO TARGET LESION WAS LOCATED IN THE PROXIMAL TO DISTAL LEFT CRCUMFLEX ARTERY. PCI WAS PERFORMED WITH AN UNSPECIFIED IVUS AND AN UNSPECIFIED BALLOON CATHETER. A 2.5 X 18MM NON BSC STENT WAS IMPLANTED AT 8ATMS, THEN A 2.25 X 12MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED AT 16ATMS. POST PROCEDURE, ANURIA OCCURRED AND THE PATIENT HAD HEMODYNAMIC INSTABILITY AND MULTIPLE ORGAN FAILURE. CONTINUOUS HEMOFILTRATION AND CONTINUOUS HE-MODIAFILTRATION(CHDF) WERE ADMINISTERED. AN INTRAAORTIC BALLOON PUMP (IABP) AND PERCUTANEOUS CARDIOPULMONARY SUPPORT DEVICE (PCPS) WERE IN PLACE. CONTINUOUS RED CELL CONCENTRATES MANNITOL ADENINE PHOSPHATE (RCC) AND CATECHOLAMINE WERE ADMINISTERED THE NEXT DAY THE PERCUTANEOUS CARDIOPULMONARY SUPPORT DEVICE(PCPS) WAS REMOVED DUE TO PLASMA EXTRAVASATION. ANURIA CONTINUED AND THE PATIENT'S BILIRUBIN WAS INCREASING DUE TO THE MULTIPLE ORGAN FAILURE. THE ISSUE WAS NOT RESOLVED AND THE PATIENT EXPIRED THIRTEEN DAYS POST ADMISSION. THE PHYSICIAN FELT THE ACUTE MYOCARDIAL INFARCTION CAUSED THE PATIENT'S MULTIPLE ORGAN FAILURE WITH NO RELATIONSHIP BETWEEN THE STENT AND THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98205 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412220

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death