BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1673186 · Received April 29, 2010

    Report

    Report Number
    2953200-2010-00750
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    January 23, 2010
    Report Date
    October 21, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVAL RESULTS AND CONCLUSION: MULTIPLE ORGAN FAILURE.

    Additional Manufacturer Narrative · 1

    PATIENT HAD A HISTORY OF HYPERTENSION, PRIOR PCI AND PRIOR MYOCARDIAL INFARCTION. THE PATIENTS CARDIAC STATUS AT TIME OF INDEX PROCEDURE WAS STABLE ANGINA. DURING THE PREVIOUSLY REPORTED CABG THE RPL AND LAD WERE TREATED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A 2.75 MM DIAMETER X 14 MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN THE RCA OF A PT WITH NO ISSUE REPORTED. DURING THE PROCEDURE, TWO OTHER ENDEAVOR RX DRUG-ELUTING CORONARY STENTS WERE DEPLOYED TO TARGET LESION (MFR REPORT TEMP# 2953200-2010-00748, 2953200-2010-00749). IT WAS REPORTED THAT THE PT HAD BYPASS SURGERY 9 WEEKS POST IMPLANT FOR TREATMENT OF A LESION IN THE LMT-LAD. COMMUNICATION FROM THE FIELD REPORTED THAT AS THE PT HAD BEEN SUFFERING FROM RENAL FAILURE, HAEMOSTATIC DRAINAGE WAS REPEATEDLY PERFORMED BUT THE PT CONDITION REMAINED POOR. RE-OPEN CHEST SURGERY AND FURTHER HAEMOSTATIC DRAINAGE WERE PERFORMED; HOWEVER, THE PT DIED APPROXIMATELY 6 WEEKS POST CABG. A COMMENT FROM THE PHYSICIAN CONFIRMED THAT THE CAUSE OF DEATH IS MULTIPLE ORGAN FAILURE AND IS NOT ASSOCIATED WITH THE RELEVANT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000968600

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death